Public Use Dataset Annotated eCRF
Bleeding and Thrombosis During ECMO
(BATE)
CPCCRN Protocol Number 048
____________________________________________________
Collaborative Pediatric Critical Care Research Network Eunice Kennedy Shriver National Institute for Child
Health and Human Development (NICHD)
Protocol Version 1.0
Version Date: September 26, 2012
Annotated eCRF Version 1.0
Version Date: February 16, 2016
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Table of Contents Notes ....................................................................................................................................................................... 3 ECMO Eligibility: ................................................................................................................................................. 4 ECMO Demographics: ......................................................................................................................................... 5 ECMO Diagnoses: ................................................................................................................................................. 6 ECMO Technology Dependence: ........................................................................................................................ 7 ECMO Hospitalization Dates and Death Information: ..................................................................................... 8 ECMO Physical Measurements: ......................................................................................................................... 9 ECMO Vital Measurements: ............................................................................................................................. 10 ECMO Baseline Ventilator Settings: ................................................................................................................ 11 ECMO Baseline Complete Blood Count w/o diff: ........................................................................................... 12 ECMO Baseline Arterial Blood Gases: ............................................................................................................. 13 ECMO Baseline Chemistries: ............................................................................................................................ 14 ECMO Baseline Coagulation Labs: .................................................................................................................. 17 ECMO Infection Information: .......................................................................................................................... 19 ECMO Vasoactive-Inotropic Score v1.0: ......................................................................................................... 20 ECMO Functional Status Assessments:............................................................................................................ 22 ECMO Initiation of ECMO: .............................................................................................................................. 23 ECMO Equipment and Setup: ......................................................................................................................... 24 ECMO Heparin Units for Circuit Priming: .................................................................................................... 26 ECMO Cannulation Characteristics: ............................................................................................................... 27 ECMO Related Daily Data v1.0: ...................................................................................................................... 34 ECMO Related Daily Data v2.0: ....................................................................................................................... 42 ECMO Related Daily Data v3.0: ...................................................................................................................... 50 ECMO Total Heparin Dose per Day: ............................................................................................................... 58 ECMO Ventilator Settings: ................................................................................................................................ 59 ECMO Complete Blood Count w/o diff: ........................................................................................................... 60 ECMO Arterial Blood Gases: ............................................................................................................................ 61 ECMO Chemistries: ........................................................................................................................................... 62 ECMO Coagulation Labs: ................................................................................................................................. 65 ECMO Daily Parameter Goals: ......................................................................................................................... 67 ECMO Blood Product & Medication Information: ........................................................................................ 70 ECMO Organ Systems: ...................................................................................................................................... 72
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Annotations key
Notes
StudySubjectID was replaced by PudID, sequential integers, that uniquely identifies a patient across datasets, it does not contain information about original site or medical record number. Occurrence and ItemGroupRepatKey are also unique subject identifiers. All out of range and other questionable data have been included in the public use datasets. Sensitive and/or identifying information entered in free text fields have been removed from the public use datasets. 'Date' variables are replaced with 'day' variables. Day variables are populated with the number of days since the reference date, ICU admission date. ICU admission date is coded as 0 (Day 0) and all other dates will be recoded as number of days after Day 0 (if any dates occur before the ICU admission day, these dates will have a negative value).
Table name
Value not provided
Column name followed by # (numeric field) or $ (character field)
Format (name) Code list
Calculated / Derived variable
Table name_Child table name
Variable in Question Group
Conditional choice set
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ECMO Eligibility:
Eligibility (1 of 1)
Inclusion1, #
Inclusion2, #
Inclusion3, #
YesNo1=Yes 0=No
PtEligible, #
Exclusion1, #
YesNo1=Yes 0=No
PudID # ItemGroupRepeatKey # Occurrence #
ScreenDay, #
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ECMO Demographics:
Additional / derived variables included in the DEMOG dataset: Variable Type Label Algorithm / Notes
RACE1 # American Indian or Alaska Native 1 = Yes, 0 = No
RACE2 # Asian 1 = Yes, 0 = No
RACE3 # Black or African American 1 = Yes, 0 = No
RACE4 # Native Hawaiian or Other Pacific Islander 1 = Yes, 0 = No
RACE5 # White 1 = Yes, 0 = No
RACE92 # Unknown or Not Reported 1 = Yes, 0 = No
Demog (1 of 1)
Sex,#
Ethnicity, #
GestationAge,#
Sex1 = Male 2 = Female
Ethnic 1 = Hispanic or Latino 2= Not Hispanic or Latino 92 = Unknown or Not Reported
PudID # Occurrence # ItemGroupRepeatKey #
BirthDay, #
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ECMO Diagnoses:
* excluded values: Diagnoses_Second with SecondDx = 15 (HIV), DIAGNOSES_CHRONIC with ChronicDxOther = 'HIV infection'
Diagnoses (1 of 1)
PrimaryDx, #
SecondDxYN, #
SecondDxOther, $SecondDx, #
ChronicDxOther, $ChronicDx, #
ChronicDxYN, #
PrimDX 1=Airway/tracheal abnormality, obstruction, surgery 2=Asthma 3=Cancer 4=Cardiac arrest 5=Cardiovascular disease – acquired 6=Cardiovascular disease – arrhythmia 7=Cardiovascular disease – congenital 8=Central nervous system infection 9=Congenital anomaly or chromosomal defect 10=Diabetes (non‐DKA) 11=Diabetic ketoacidosis (DKA) 12=Drowning / asphyxia / hanging 13=Gastrointestinal disorder 14=Hematologic disorder 15=HIV infection 16=Hypoxic ischemic encephalopathy 17=Ingestion (drug or toxin) 18=Medical device malfunction 19=Musculoskeletal condition 20=Neurological miscellaneous 21=Neurological ‐ cords, bones 22=Neurological ‐ vascular malformations 23=Neurological CSF related (hydrocephalus / Chiari / fenestrations / arachnoid cysts) 24=Pertussis 25=Pneumonia / bronchiolitis 26=Renal failure 27=Respiratory distress / failure 28=Scoliosis / spine surgery 29=Seizures 30=Sepsis / SIRS / septic shock 31=Shock (non‐septic) 32=Stroke / cerebral ischemia / cerebral infarction 33=Suicide attempt 34=Transplant 35=Trauma 90=Other
Diagnoses_Second
Diagnoses_Chronic
YesNo 1=Yes 0=No
YesNo1=Yes 0=No
ChronDX 1=Asthma 2=Cancer 3=Cardiovascular disease – acquired 4=Cardiovascular disease – arrhythmia 5=Cardiovascular disease – congenital 6=Chronic renal failure 7=Chronic lung disease (BPD, CF) 8=Congenital anomaly or chromosomal defect 9=Diabetes 10=Musculoskeletal 11=Neurologic ‐ static encephalopathy 12=Neurologic ‐ Other chronic condition 13=Neurologic ‐ chronic seizures 14=Transplant 90=Other
PudID # Occurrence # ItemGroupRepeatKey #
PrimaryDxOther, $
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ECMO Technology Dependence:
TechDepend (1 of 1)
Gastrostomy, #
OtherFeedTube, #
Oxygen, #
Tracheostomy, #
HomeVent, #
VentricularShunt, #
Dialysis, #
VascularAccess, #
YesNo 1=Yes 0=No
PudID # Occurrence # ItemGroupRepeatKey #
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ECMO Hospitalization Dates and Death Information:
Dates (1 of 1)
HospAdmitTime, $
ICUAdmitTime, $
ICUDisTime, $
HospDisTime, $
HospVitalStatus, #
DeathTime, $
WithdrawOfSupport, #
VitStat1=Alive 0=Dead
YesNo1=Yes 0=No
HOSPADMITDAY, #
PudID # Occurrence # ItemGroupRepeatKey #
ICUADMITDAY, #
ICUDISDAY, #
HOSPDISDAY, #
DEATHDAY, #
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ECMO Physical Measurements:
PM (1 of 1)
Height, # Weight, #
HeadCirc, # HeadCircND, #
NotDoc94=Head circumference not documented
PudID # Occurrence # ItemGroupRepeatKey #
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ECMO Vital Measurements:
VM (1 of 1)
HeartRate, #
SBP, #
MeanBP, #
Temperature, #
TempTime, $
DBP, #
RespRate, #
CardioTime, $
PupilTime, $
PupilReflex, #
Pupil 1=Both reactive 2=One non‐reactive (> 3mm) 3=Both non‐reactive (> 3mm) 4=Both pupils
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ECMO Baseline Ventilator Settings:
BaseVent (1 of 1)
PS, #
PIP, #
VTSet, #
VTExhaled, #
VentilatorRate, #
VentMode, # VentModeOther, $
VentTime, $
MAP, #
PEEP, #
FiO2, #
HFOVFrequency, #
HFOVAmplitude, #
VentMode1=Pressure Control 2=PRVC 3=HFOV 4=Volume Control 5=Non‐invasive Ventilation 6=Pressure Support and CPAP 90=Other
VentSupportYN, # YesNo1=Yes 0=No VENTDAY, #
PudID # Occurrence # ItemGroupRepeatKey #
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ECMO Baseline Complete Blood Count w/o diff:
BaseCBC (1 of 1)
WBC, # Platelet, # HCTPct, # HgbMass, #CBCNoDiffTime, $
ItemGroupRepeatKey # Occurrence # PudID #
CBCNODIFFDAY, #
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ECMO Baseline Arterial Blood Gases:
BaseABG (1 of 1)
ABGTime, $ pHArtBld, #
PCO2ArtBld, #
PaO2ArtBld, #
HCO3, #
SaO2, #
ABGFiO2, #
CaIonArtBld, #
CaIonArtBldUnit, #
Ion1=mg/dL, 2=mmol/L
ABGDAY, #
PudID # Occurrence # ItemGroupRepeatKey #
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ECMO Baseline Chemistries:
Note: Although the case report form reflects HCO3 as being collected, the lab value being provided in this data field represents total CO2.
BaseBMP (1 of 1)
BMPTime, $ Sodium, # Potassium, # Glucose, #BUNmg, # Creatinine, #Chloride, # Bicarbonate, #
ItemGroupRepeatKey # Occurrence # PudID #
BMPDAY, #
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ECMO Baseline Chemistries:
LDH, # ALT, # AST, # ALP, # TotalBilirubin, # ChemTimeOne, $
BaseChemOne (1 of 1)
PudID # Occurrence # ItemGroupRepeatKey #
CHEMDAYONE, #
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ECMO Baseline Chemistries:
Calciummg, # TotalProtein, # LactateUnit, #
Albumin, # ChemTimeTwo, $ Lactate, #
Lactate1=mg/dL 2=mmol/L
BaseChemTwo (1 of 1)
PudID # Occurrence # ItemGroupRepeatKey #
CHEMDAYTWO, #
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ECMO Baseline Coagulation Labs:
BaseCoag (1 of 1)
CoagTime, $ PT, # PTT, # INR, # COAGDAY, #
PudID # Occurrence # ItemGroupRepeatKey #
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ECMO Baseline Coagulation Labs:
OtherCoagTime, $ Fibrinogen, #
FibrinogenUnit, #
ACT, # ATIIICoag, # AntiXa, #
fib1=mg/dL 2=ng/mL
BaseOtherCoag (1 of 1)
ItemGroupRepeatKey # Occurrence # PudID #
OTHERCOAGDAY, #
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ECMO Infection Information:
Additional / derived variables included in the INFECTION dataset: Variable Type Label Algorithm / Notes BaseUnprovenInfectType1 # Bacterial 1 = Yes, 0 = No
BaseUnprovenInfectType2 # Fungal 1 = Yes, 0 = No
BaseUnprovenInfectType3 # Viral 1 = Yes, 0 = No
Infection (1 of 1)
BaseFungalInfectTime, $
BaseFungalInfect, #
BaseViralInfectTime, $
BaseViralInfect, #
BaseUnprovenInfect, #
Infection_BaseViral
Infection_BaseFungal
YesNo1=Yes 0=No
YesNo1=Yes 0=No
YesNo1=Yes 0=No
Value not provided
Value not provided
PudID # Occurrence # ItemGroupRepeatKey #
BASEFUNGALINFECTDAY, #
BASEVIRALINFECTDAY, #
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ECMO Vasoactive‐Inotropic Score v1.0:
NOTE: Two versions of the Vasoactive‐Inotropic Score exist; however, the raw dataset has stacked versions, VIS_ALLVERSIONS.
VIS (1 of 1)
VISBolusGiven, #
VISIsoproterenol, #
VISVasopressin, #
VISPhenylephrine, #
VISNorepinephrine, #
VISEpinephrine, #
VISMilrinone, #
VISNitroprusside, #
VISDobutamine, #
VISDopamine, #
VISTime, $
YesNo1=Yes 0=No
PudID # Occurrence # ItemGroupRepeatKey #
VISDAY, #
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ECMO Vasoactive‐Inotropic Score v2.0:
NOTE: Two versions of the Vasoactive‐Inotropic Score exist; however, the raw dataset has stacked versions, VIS_ALLVERSIONS.
VIS_v2 (1 of 1)
VISDopamine, #
VISDobutamine, #
VISNitroprusside, #
VISMilrinone, #
VISEpinephrine, #
VISNorepinephrine, #
VISPhenylephrine, #
VISVasopressin, #
VISIsoproterenol, #
VISBolusGiven, #
VISTime, $
VISVasopressinUnit, #
YesNo 1=Yes 0=No
VasoUnit1 =munits/kg/hr 2 = units/kg/hr 3 = units/hr 4 = munits/kg/min 5 = units/kg/min
VISDAY, #
PudID # Occurrence # ItemGroupRepeatKey #
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ECMO Functional Status Assessments:
NOTE: The SEVERITY dataset has an additional unique identifier that indicates a baseline or discharge measurement.
Severity (1 of 1)
POPCScore, INT
PCPCScore, INT
FSSMental, INT
FSSSensory, INT
FSSCommun, INT
FSSMotor, INT
FSSFeeding, INT
FSSResp, INT
PCPC1=1 – Normal 2=2 – Mild disability 3=3 – Moderate disability 4=4 – Severe disability 5=5 – Coma/vegetative state 6=6 – Brain Death
FSS1=Normal 2=Mild dysfunction 3=Moderate dysfunction 4=Severe dysfunction 5=Very severe dysfunction
POPC1=1 – Good 2=2 – Mild disability 3=3 – Moderate disability 4=4 – Severe disability 5=5 – Coma/vegetative state 6=6 – Brain Death
PudID # Occurrence # ItemGroupRepeatKey #
StudyEvent, $
PCPCDAY, #
FSSDAY, #
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ECMO Initiation of ECMO:
Initiation (1 of 1)
ECMOStartTime, $
ModeECMOOther, $ ModeECMO, #
MAS, #
IndicationECMO, #
LocationsECMO, #
CCAM, #
PPHTN, #
CDH, #
OpProcedure, #
OpProcedureTime, $
CBP, #
CPBTime, $
ExitToECMO, #
CPBToECMO, #
Mode 1=VA 2=VA + V 3=VA‐VV 4=VV 5=VV‐VA 6=VVA 7=VVDL 8=VVDL + V 90=Other
ECMOCare1=PICU 2=NICU 3=CICU
ECMOInd1=Respiratory 2=Cardiac 3=ECPR
YesNo 1=Yes 0=No
ECMOSTARTDAY, #
PudID # Occurrence # ItemGroupRepeatKey #
OPPROCEDUREDAY, #
CPBDAY, #
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ECMO Equipment and Setup:
RollerPumpID, #
RollerPump, #
CentrifugePumpID, #
CentrifugePump, #
HollowFiberVendorOther, $
HollowFiberVendor, #
HollowFiber, #
OxygenatorSize, # SiliconeLung, #
OxygenCoatingType, #
OxygenCoating, #
OxygenCoatingTypeOther, $
TubingVendor, $
TubingCoating, #
TubingCoatingType, #
TubingCoatingTypeOther, $ YesNo 1=Yes 0=No
HiFiber1=Infinity 2=Lilliput 3=Medos 4=Medtronic 5=Medtronic minimax 6=Quadrox 7=Quadrox‐D 8=Quadrox‐iD 9=Terumo 90=Other
Coat1=Bioline 2=Carmeda 3=Safeline 90=Other
Equipment_v2 (1 of 2)
PudID # Occurrence # ItemGroupRepeatKey #
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ECMO Equipment and Setup:
NonBloodPrimeCorrect, #
MethodPrimeCircuit, #
Prime1=Non‐blood (clear) 2=Blood product
YesNo 1=Yes 0=No
NonBloodPrimeVolume, #
NonBloodPrimeMethod, #
NonBloodPrimeOther, $
NegativePressure, #
BladderReservoir, #
CircuitBridgeConfig, #
HeparinBolus, #
HeparinBolusDose, #
FirstACTResult, #
FirstACTTime, $
Strategy1=Exchange transfusion 2=Hemofiltration 90=Other
Circuit1=In‐line with stopcock 2= In‐line but clamped 3=Not in‐line
FirstACTTooHigh, #
YesNo1=Yes 0=No
HepAfterECMOTime, $
Equipment_v2 (2 of 2)
TooHigh 1=Too high to read
PudID # Occurrence # ItemGroupRepeatKey #
FIRSTACTDAY, #
HEPARINAFTERECMODAY, #
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ECMO Heparin Units for Circuit Priming:
HeparinPrime (1 of 1)
HeparinPrimingUnits, #
PudID # Occurrence # ItemGroupRepeatKey #
HEPARINUNITDAY, #
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ECMO Cannulation Characteristics:
CannulaStartTime, $
CanRemoveStopTime, $
StatusAtCanRemove, #
FlowAtCanRemoveUnit, # FlowAtCanRemove, #
Dstat1=Alive 0=Dead 2=Transition to VAD
FRUnit1=mL/min 2=L/min
Recannulated, #
YesNo 1=Yes 0=No
Cannulation_v2 (1 of 1)
PudID # Occurrence # ItemGroupRepeatKey #
CANNULASTARTDAY, #
CANNULASTOPDAY, #
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ECMO Cannulation Characteristics :
Cannulation_Venous_v2 (1 of 1)
VenousCanPlaceTime, $ VenousCannulaSite, #
VenousCannulaSiteOther, $
VenousCannulaID, #
VenousCanRemoveTime, $
VeinSite1=Right Internal Jugular Vein (RIJV) 2=Left Internal Jugular Vein (LIJV) 3=Right Femoral Vein (RFV) 4=Left Femoral Vein (LFV) 5=Right Atrium (RA) 90=Other
PudID # Occurrence # ItemGroupRepeatKey #
VENOUSCANPLACEDAY, # VENOUSCANREMOVEDAY, #
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ECMO Cannulation Characteristics:
ArterialCanPlaceTime, $
ArterialCannulaSite, # ArterialCannulaSiteOther, $
ArterialCannulaID, #
ArterialCanRemoveTime, $
ArtSite 1=Right Common Carotid Artery (RCCA) 2=Left Common Carotid Artery (LCCA) 3=Right Femoral Artery (RFA) 4=Left Femoral Artery (LFA) 5=Left Atrium (LA) 6=Pulmonary Artery (PA) 7=Aorta 90=Other
Cannulation_Arterial_v2 (1 of 1)
PudID # Occurrence # ItemGroupRepeatKey #
ARTERIALCANREMOVEDAY, #
ARTERIALCANPLACEDAY, #
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ECMO Cannulation Characteristics:
DLCCanPlaceTime, $ DLCCannulaSite, #
DLCCannulaSiteOther, $
DLCCannulaID, # DLCCanRemoveTime, $
DLCSite1=Right Internal Jugular Vein (RIJV) 2=Left Internal Jugular Vein (LIJV) 3=Right Femoral Vein (RFV) 4=Left Femoral Vein (LFV) 90=Other
Cannulation_DLC_v2 (1 of 1)
DLCCANREMOVEDAY, #
PudID # Occurrence # ItemGroupRepeatKey #
DLCCANPLACEDAY, #
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ECMO Cannulation Characteristics:
Cannulation_Cephalad_v2 (1 of 1)
CephaladCanPlaceTime, $ CephaladCanRemoveTime, $ CEPHALADCANREMOVEDAY, #
PudID # Occurrence # ItemGroupRepeatKey #
CEPHALADCANPLACEDAY, #
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ECMO Cannulation Characteristics:
Cannulation_LAD_v2 (1 of 1)
LADCanPlaceTime, $ LADCanRemoveTime, $ LADCANPLACEDAY, #
PudID # Occurrence # ItemGroupRepeatKey #
LADCANREMOVEDAY, #
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ECMO Cannulation Characteristics:
Cannulation_DPC_v2 (1 of 1)
DPCCanPlaceTime, $
DPCCannulaSite, #
DPCSite1=Right arm 2=Left arm 3=Right leg 4=Left leg 90=Other
DPCCannulaSiteOther, $ DPCCanRemoveTime, $ DPCCANPLACEDAY, #
PudID # Occurrence # ItemGroupRepeatKey #
DPCCANREMOVEEDAY, #
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ECMO Related Daily Data v1.0:
NOTE: Three versions of the ECMO Related Daily Data exist, including the tables embedded within the CRF; however, the raw dataset has stacked versions, ECMODAILY_ALLVERSIONS, ECMODAILY_INFECT_ALLVERSIONS.
ECMODaily (1 of 8)
NewInfect, #
NewInfectTime, $
RemovedFromECMO, #
YesNo1=Yes 0=No
ECMODaily_Infect
Value not provided
PudID # Occurrence # ItemGroupRepeatKey #
STUDYDAY, #
NEWINFECTDAY, #
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ECMO Related Daily Data v1.0:
ECMODaily (2 of 8)
LabSampleLoss, #
ChestTubeOutput, #
LabSampleSiteLoss, #
ChestTubeSiteLoss, #
SurgicalSiteLoss, #
CannulaSiteLoss, #
PulmBleed, #
GastroIntestBleed, #
TransIntracranBleed, #
GUBleed, #
NewIntracranBleed, #
ChestTubeOutputND, #
LabSampleLossND, #
NoCT1=No chest tube
NotTab98=Not tabulated
YesNo 1=Yes 0=No
PudID # Occurrence # ItemGroupRepeatKey #
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ECMO Related Daily Data v1.0:
ECMODaily (3 of 8)
ThromEmbolus, #
ThromIschemia, #
EmbolusStatus, #
IntracardiacStatus, #
ThromIntracardiac, #
AortopulmStatus, #
ThromAortopulm, #
HemolysisStatus, #
ThromHemolysis, #
ThromOtherOccur, #
ThromOtherEvent, $
ThromOtherStatus, #
IschemiaStatus, #
IntraInfarctStatus, #
ThromIntraInfarct, #
YesNo 1=Yes 0=No
NBSW 1=New 2=Better 3=Same 4=Worse
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ECMO Related Daily Data v1.0:
ECMODaily (4 of 8)
ThromClotHappenOne, #
ThromClotCVVHOne, #
ThromClotOxygenOne, #
ThromClotTubeOne, #
ThromClotArterialCanOne, #
ThromClotPumpOne, #
ThromClotVenousCanOne, #
ChgEntireCiruitOne, #
ThromClotOthCircuitOne, #
ThromClotHemofilterOne, #
ThromClotBridgeOne, #
CircuitChgArterialCanOne, # CircuitChgOthCircuitOne, #
CircuitChgVenousCanOne, #
CircuitChgPumpOne, #
CircuitChgTubeOne, #
CircuitChgCVVHOne, #
CircuitChgHemofilterOne, #
CircuitChgBridgeOne, #
CircuitChgBladderOne, #
CircuitChgOxygenOne, #
ThromClotBladderOne, # YesNo1=Yes 0=No
YesNo1=Yes 0=No
YesNo1=Yes 0=No
YesNo 1=Yes 0=No
PudID # Occurrence # ItemGroupRepeatKey #
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ECMO Related Daily Data v1.0:
ECMODaily (5 of 10)
CircuitChgNonThrombOne, #
NonThromChgBridgeOne, #
NonThromChgHemofilterOne, #
NonThromChgPumpOne, #
NonThromChgVenousCanOne, #
NonThromChgArterialCanOne, # NonThromChgOthCircuitOne, #
CircuitChgCompSpecifyOne, #
CircuitChgCompOne, #
NonThromChgEntireCiruitOne, #
NonThromChgOxygenOne, #
NonThromChgBladderOne, #
NonThromChgCVVHOne, #
NonThromChgTubeOne, #
Comp 1=Cardiac arrest 2=Hypoxemia requiring hand ventilation or increasing ventilator settings 3=Increase in vasoactive agents or bolus vasoactive administration 4=Thrombosis requiring further intervention 5=Bleeding requiring transfusion
YesNo1=Yes 0=No
YesNo 1=Yes 0=No
PudID # ItemGroupRepeatKey # Occurrence #
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ECMO Related Daily Data v1.0:
ECMODaily (6 of 8)
ThromClotHemofilterTwo, #
ThromClotPumpTwo, #
ThromClotOthCircuitTwo, #
ChgEntireCiruitTwo, #
ThromClotArterialCanTwo, #
ThromClotTubeTwo, #
ThromClotBridgeTwo, #
ThromClotCVVHTwo, #
ThromClotBladderTwo, #
ThromClotOxygenTwo, #
ThromClotHappenTwo, #
ThromClotVenousCanTwo, #
YesNo1=Yes 0=No
YesNo 1=Yes 0=No
PudID # Occurrence # ItemGroupRepeatKey #
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ECMO Related Daily Data v1.0:
ECMODaily (7 of 8)
CircuitChgBladderTwo, #
CircuitChgCVVHTwo, #
CircuitChgCompTwo, #
CircuitChgCompSpecifyTwo, #
CircuitChgTubeTwo, # CircuitChgOthCircuitTwo, #
CircuitChgArterialCanTwo, #
CircuitChgOxygenTwo, #
CircuitChgVenousCanTwo, #
CircuitChgPumpTwo, #
CircuitChgHemofilterTwo, #
CircuitChgBridgeTwo, #
Comp 1=Cardiac arrest 2=Hypoxemia requiring hand ventilation or increasing ventilator settings 3=Increase in vasoactive agents or bolus vasoactive administration 4=Thrombosis requiring further intervention 5=Bleeding requiring transfusion
YesNo1=Yes 0=No
YesNo 1=Yes 0=No
PudID # Occurrence # ItemGroupRepeatKey #
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ECMO Related Daily Data v1.0:
ECMODaily (8 of 8)
PFHTime, $
PlasmaFreeHgb, # PlasmaFreeHgbND, #
RequireCVVH, #
ClampedTube, #
FlowRateUnit, #
SvO2Site, #
FlowRate, #
SvO2, #
SvO2Time, ST
SvO2ND, #
RequireHemofiltration, #
RequirePlasma, #
YesNo 1=Yes 0=No
SvO2Site1=Patient 2=Circuit
NotDone95=Not done
FRUnit 1=mL/min 2=L/min
ItemGroupRepeatKey # Occurrence # PudID #
PFHDAY, #
SVO2DAY, #
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ECMO Related Daily Data v2.0:
ECMODaily_v2 (1 of 8)
NewInfect, #
NewInfectTime, $
RemovedFromECMO, #
YesNo1=Yes 0=No
ECMODaily_Infect
ItemGroupRepeatKey # Occurrence # PudID #
STUDYDAY, #
NEWINFECTDAY, # Value not provided
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ECMO Related Daily Data v2.0:
ECMODaily_v2 (2 of 8)
LabSampleLoss, #
ChestTubeOutput, #
LabSampleSiteLoss, #
ChestTubeSiteLoss, #
SurgicalSiteLoss, #
CannulaSiteLoss, #
PulmBleed, #
GastroIntestBleed, #
TransIntracranBleed, #
GUBleed, #
NewIntracranBleed, #
ChestTubeOutputND, #
LabSampleLossND, #
NoCT1=No chest tube
NotTab98=Not tabulated
YesNo 1=Yes 0=No
ItemGroupRepeatKey # Occurrence # PudID #
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ECMO Related Daily Data v2.0:
ECMODaily_v2 (3 of 8)
ThromEmbolus, #
ThromIschemia, #
EmbolusStatus, #
IntracardiacStatus, #
ThromIntracardiac, #
AortopulmStatus, #
ThromAortopulm, #
HemolysisStatus, #
ThromHemolysis, #
ThromOtherOccur, #
ThromOtherEvent, $
ThromOtherStatus, #
IschemiaStatus, #
IntraInfarctStatus, #
ThromIntraInfarct, #
YesNo 1=Yes 0=No
NBSW 1=New 2=Better 3=Same 4=Worse
ItemGroupRepeatKey # Occurrence # PudID #
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ECMO Related Daily Data v2.0:
ECMODaily_v2 (4 of 8)
ThromClotHappenOne, #
ThromClotCVVHOne, #
ThromClotOxygenOne, #
ThromClotTubeOne, #
ThromClotArterialCanOne, #
ThromClotPumpOne, #
ThromClotVenousCanOne, #
ChgEntireCiruitOne, #
ThromClotOthCircuitOne, #
ThromClotHemofilterOne, #
ThromClotBridgeOne, #
CircuitChgArterialCanOne, # CircuitChgOthCircuitOne, #
CircuitChgVenousCanOne, #
CircuitChgPumpOne, #
CircuitChgTubeOne, #
CircuitChgCVVHOne, #
CircuitChgHemofilterOne, #
CircuitChgBridgeOne, #
CircuitChgBladderOne, #
CircuitChgOxygenOne, #
ThromClotBladderOne, # YesNo1=Yes 0=No
YesNo1=Yes 0=No
YesNo1=Yes 0=No
YesNo 1=Yes 0=No
ItemGroupRepeatKey # Occurrence # PudID #
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ECMO Related Daily Data v2.0:
ECMODaily_v2 (5 of 8)
CircuitChgNonThrombOne, #
NonThromChgBridgeOne, #
NonThromChgHemofilterOne, #
NonThromChgPumpOne, #
NonThromChgVenousCanOne, #
NonThromChgArterialCanOne, # NonThromChgOthCircuitOne, #
CircuitChgCompSpecifyOne, #
CircuitChgCompOne, #
NonThromChgEntireCiruitOne, #
NonThromChgOxygenOne, #
NonThromChgBladderOne, #
NonThromChgCVVHOne, #
NonThromChgTubeOne, #
Comp 1=Cardiac arrest 2=Hypoxemia requiring hand ventilation or increasing ventilator settings 3=Increase in vasoactive agents or bolus vasoactive administration 4=Thrombosis requiring further intervention 5=Bleeding requiring transfusion
YesNo1=Yes 0=No
YesNo 1=Yes 0=No
ItemGroupRepeatKey # Occurrence # PudID #
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ECMO Related Daily Data v2.0:
ECMODaily_v2 (6 of 8)
ThromClotHemofilterTwo, #
ThromClotPumpTwo, #
ThromClotOthCircuitTwo, #
ChgEntireCiruitTwo, #
ThromClotArterialCanTwo, #
ThromClotTubeTwo, #
ThromClotBridgeTwo, #
ThromClotCVVHTwo, #
ThromClotBladderTwo, #
ThromClotOxygenTwo, #
ThromClotHappenTwo, #
ThromClotVenousCanTwo, #
YesNo1=Yes 0=No
YesNo 1=Yes 0=No
PudID # Occurrence # ItemGroupRepeatKey #
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ECMO Related Daily Data v2.0:
ECMODaily_v2 (7 of 8)
CircuitChgBladderTwo, #
CircuitChgCVVHTwo, #
CircuitChgCompTwo, #
CircuitChgCompSpecifyTwo, #
CircuitChgTubeTwo, # CircuitChgOthCircuitTwo, #
CircuitChgArterialCanTwo, #
CircuitChgOxygenTwo, #
CircuitChgVenousCanTwo, #
CircuitChgPumpTwo, #
CircuitChgHemofilterTwo, #
CircuitChgBridgeTwo, #
Comp 1=Cardiac arrest 2=Hypoxemia requiring hand ventilation or increasing ventilator settings 3=Increase in vasoactive agents or bolus vasoactive administration 4=Thrombosis requiring further intervention 5=Bleeding requiring transfusion
YesNo1=Yes 0=No
YesNo 1=Yes 0=No
ItemGroupRepeatKey # Occurrence # PudID #
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ECMO Related Daily Data v2.0:
PFHTime, $
PlasmaFreeHgb, # PlasmaFreeHgbND, #
RequireCVVH, #
ClampedTube, #
FlowRateUnit, #
SvO2Site, #
FlowRate, #
SvO2, #
SvO2Time, $
SvO2ND, #
RequireHemofiltration, #
RequirePlasma, #
YesNo1=Yes 0=No
SvO2Site1=Patient 2=Circuit
NotDone95=Not done
FRUnit 1=mL/min 2=L/min
ECMODaily_v2 (8 of 8)
ItemGroupRepeatKey # Occurrence # PudID #
PFHDAY, #
SVO2DAY, #
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ECMO Related Daily Data v3.0:
ECMODaily_v3 (1 of 8)
NewInfect, #
NewInfectTime, $
RemovedFromECMO, #
YesNo1=Yes 0=No
ECMODaily_Infect
Value not providedNEWINFECTDAY, #
STUDYDAY, #
ItemGroupRepeatKey # Occurrence # PudID #
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ECMO Related Daily Data v3.0:
ECMODaily_v3 (2 of 8)
LabSampleLoss, #
ChestTubeOutput, #
LabSampleSiteLoss, #
ChestTubeSiteLoss, #
SurgicalSiteLoss, #
CannulaSiteLoss, #
PulmBleed, #
GastroIntestBleed, #
TransIntracranBleed, #
GUBleed, #
NewIntracranBleed, #
ChestTubeOutputND, #
LabSampleLossND, #
NoCT1=No chest tube
NotTab98=Not tabulated
YesNo 1=Yes 0=No
PudID # Occurrence # ItemGroupRepeatKey #
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ECMO Related Daily Data v3.0:
ECMODaily_v3 (3 of 8)
ThromEmbolus, #
IntraInfarctThromType, #
EmbolusStatus, #
IntracardiacStatus, #ThromIntracardiac, #
AortopulmStatus, #ThromAortopulm, #
HemolysisStatus, #ThromHemolysis, #
ThromOtherOccur, #
ThromOtherStatus, #
IntraInfarctNonThromStatus, #
IntraInfarctThromStatus, #
IntraInfarct, #
YesNo 1=Yes 0=No
NBSW1=New 2=Better 3=Same 4=Worse
IntraInfarctNonThromType, #
ThromOtherEvent, #
Ischemia, #
IschemiaThromType, #
IschemiaNonThromType, #
IschemiaThromStatus, #
IschemiaNonThromStatus, #
ItemGroupRepeatKey # Occurrence # PudID #
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ECMO Related Daily Data v3.0:
ECMODaily_v3 (4 of 8)
ThromClotHappenOne, #
ThromClotCVVHOne, #
ThromClotOxygenOne, #
ThromClotTubeOne, #
ThromClotArterialCanOne, #
ThromClotPumpOne, #
ThromClotVenousCanOne, #
ChgEntireCiruitOne, #
ThromClotOthCircuitOne, #
ThromClotHemofilterOne, #
ThromClotBridgeOne, #
CircuitChgArterialCanOne, # CircuitChgOthCircuitOne, #
CircuitChgVenousCanOne, #
CircuitChgPumpOne, #
CircuitChgTubeOne, #
CircuitChgCVVHOne, #
CircuitChgHemofilterOne, #
CircuitChgBridgeOne, #
CircuitChgBladderOne, #
CircuitChgOxygenOne, #
ThromClotBladderOne, # YesNo1=Yes 0=No
YesNo1=Yes 0=No
YesNo1=Yes 0=No
YesNo 1=Yes 0=No
PudID # Occurrence # ItemGroupRepeatKey #
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ECMO Related Daily Data v3.0:
ECMODaily_v3 (5 of 18
CircuitChgNonThrombOne, #
NonThromChgBridgeOne, #
NonThromChgHemofilterOne, #
NonThromChgPumpOne, #
NonThromChgVenousCanOne, #
NonThromChgArterialCanOne, # NonThromChgOthCircuitOne, #
CircuitChgCompSpecifyOne, #
CircuitChgCompOne, #
NonThromChgEntireCiruitOne, #
NonThromChgOxygenOne, #
NonThromChgBladderOne, #
NonThromChgCVVHOne, #
NonThromChgTubeOne, #
Comp 1=Cardiac arrest 2=Hypoxemia requiring hand ventilation or increasing ventilator settings 3=Increase in vasoactive agents or bolus vasoactive administration 4=Thrombosis requiring further intervention 5=Bleeding requiring transfusion
YesNo1=Yes 0=No
YesNo 1=Yes 0=No
PudID # Occurrence # ItemGroupRepeatKey #
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ECMO Related Daily Data v3.0:
ECMODaily_v3 (6 of 8)
ThromClotHemofilterTwo, #
ThromClotPumpTwo, #
ThromClotOthCircuitTwo, #
ChgEntireCiruitTwo, #
ThromClotArterialCanTwo, #
ThromClotTubeTwo, #
ThromClotBridgeTwo, #
ThromClotCVVHTwo, #
ThromClotBladderTwo, #
ThromClotOxygenTwo, #
ThromClotHappenTwo, #
ThromClotVenousCanTwo, #
YesNo1=Yes 0=No
YesNo 1=Yes 0=No
ItemGroupRepeatKey # Occurrence # PudID #
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ECMO Related Daily Data v3.0:
ECMODaily_v3 (7 of 8)
CircuitChgBladderTwo, #
CircuitChgCVVHTwo, #
CircuitChgCompTwo, #
CircuitChgCompSpecifyTwo, #
CircuitChgTubeTwo, # CircuitChgOthCircuitTwo, #
CircuitChgArterialCanTwo, #
CircuitChgOxygenTwo, #
CircuitChgVenousCanTwo, #
CircuitChgPumpTwo, #
CircuitChgHemofilterTwo, #
CircuitChgBridgeTwo, #
Comp 1=Cardiac arrest 2=Hypoxemia requiring hand ventilation or increasing ventilator settings 3=Increase in vasoactive agents or bolus vasoactive administration 4=Thrombosis requiring further intervention 5=Bleeding requiring transfusion
YesNo1=Yes 0=No
YesNo 1=Yes 0=No
PudID # Occurrence # ItemGroupRepeatKey #
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ECMO Related Daily Data v3.0:
PFHTime, $
PlasmaFreeHgb, # PlasmaFreeHgbND, #
RequireCVVH, #
ClampedTube, #
FlowRateUnit, #
SvO2Site, #
FlowRate, #
SvO2, #
SvO2Time, $
SvO2ND, #
RequireHemofiltration, #
RequirePlasma, #
YesNo1=Yes 0=No
SvO2Site1=Patient 2=Circuit
NotDone95=Not done
FRUnit 1=mL/min 2=L/min
ECMODaily_v3 (8 of 8)
ItemGroupRepeatKey # Occurrence # PudID #
PFHDAY, #
SVO2DAY, #
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ECMO Total Heparin Dose per Day:
HeparinTotal (1 of 1)
TotalHeparinDose, #
PudID # Occurrence # ItemGroupRepeatKey #
TOTALHEPARINDAY, #
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ECMO Ventilator Settings:
Vent (1 of 1)
VentTime, $
VentSupportYN, #
VentModeOther, $ VentMode, #
HFOVAmplitude, #
HFOVFrequency, #
FiO2, #
PEEP, #
MAP, #
PS, #
PIP, #
VTSet, #
VTExhaled, #
VentilatorRate, #
YesNo 1=Yes 0=No
VentMode1=Pressure control 2=PRVC 3=HFOV 4=Volume control 5=Non‐invasive ventilation 6=Pressure support and CPAP 90=Other
PudID # Occurrence # ItemGroupRepeatKey #
VENTDAY, #
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ECMO Complete Blood Count w/o diff:
CBC (1 of 1)
HgbMass, # HCTPct, # Platelet, # WBC, # CBCNoDiffTime, $
CBC_CBC
CBCNODIFFDAY, #
PudID # Occurrence # ItemGroupRepeatKey #
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ECMO Arterial Blood Gases:
ABG (1 of 1)
pHArtBld, # ABGTime, $
PCO2ArtBld, #
PaO2ArtBld, # HCO3, # SaO2, #
ABGFiO2, #
ABG_ABG
Ion1=mg/dL 2=mmol/L
CaIonArtBld, #
CaIonArtBldUnit, #
ABGDAY #
PudID # Occurrence # ItemGroupRepeatKey #
BATE Annotated eCRF
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ECMO Chemistries:
Note: Although the case report form reflects HCO3 as being collected, the lab value being provided in this data field represents total CO2.
Chemistries (1 of 2)
Potassium, # Chloride, # Bicarbonate, # BUNmg, # Creatinine, #Sodium, # BMPTime, $ Glucose, #
Chemistries_Chem
BMPDAY, #
PudID # Occurrence # ItemGroupRepeatKey #
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ECMO Chemistries:
Chemistries (2 of 2)
LDH, #
Lactate, # Calciummg, # TotalProtein, #ChemTimeTwo, $ Albumin, #
ALP, # TotalBilirubin, # ChemTimeOne, $
AST, # ALT, #
LactateUnit, #
Chemistries_ChemTwo
Chemistries_ChemOne
Lactate 1=mg/dL 2=mmol/L
CHEMDAY, #
PudID # Occurrence # ItemGroupRepeatKey #
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BATE Annotated eCRF
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ECMO Coagulation Labs:
Coag (1 of 2)
INR, # PTT, # PT, # CoagTime, $
Coag_Coag
PudID # Occurrence # ItemGroupRepeatKey #
COAGDAY, #
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ECMO Coagulation Labs:
Coag (2 of 2)
FibrinogenUnit, #
Fibrinogen, # OtherCoagTime, $ ACT, # ATIIICoag, # AntiXa, #
fib 1=mg/dL 2=ng/mL
Coag_OtherCoag
OTHERCOAGDAY, #
PudID # Occurrence # ItemGroupRepeatKey #
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ECMO Daily Parameter Goals:
GoalsChanged, #
HCTGoalLow, #
HgbGoalLow, #
PlateletGoalLow, #
PTGoalLow, #
LowPTTGoal, #
YesNo1=Yes 0=No
PTTNotDone, #
PTNotDone, #
PlateletNotDone, #
HgbNotDone, #
HCTNotDone, #
PTTNotChg, #
PTNotChg, #
PlateletNotChg, #
HgbNotChg, #
HCTNotChg, #
NotChg 2=Not changed from previous study day
NotSet99=Not Set
HighPTTGoal, #
HCTGoalHigh, #
HgbGoalHigh, #
PlateletGoalHigh, #
PTGoalHigh, #
Parameter_v2 (1 of 3)
ItemGroupRepeatKey # Occurrence # PudID #
GOALSDAY, #
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ECMO Daily Parameter Goals:
Parameter_v2 (2 of 3)
FibrinogenGoalLow, #
FibrinogenNotDone, # FibrinogenNotChg, #
PaO2GoalLow, #
LowACTGoal, #
ATIIIGoalLow, #
LowAntiXaGoal, #
FibrinogenGoalUnit, #
fib1=mg/dL 2=ng/mL
AntiXaNotDone, #
ATIIINotDone, #
ACTNotDone, #
PaO2NotDone, #
AntiXaNotChg, #
ATIIINotChg, #
ACTNotChg, #
PaO2NotChg, #
NotSet99=Not Set
NotChg 2=Not changed from previous study day
HighAntiXaGoal, #
HighACTGoal, #
FibrinogenGoalHigh, #
ATIIIGoalHigh, #
PaO2GoalHigh, #
PudID # Occurrence # ItemGroupRepeatKey #
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ECMO Daily Parameter Goals:
LowpHGoal, #
LowTempGoal, #
SvO2GoalLow, #
SaO2GoalLow, #
PaCO2NotDone, #
pHNotDone, #
TempNotDone, #
SvO2NotDone, #
SaO2NotDone, #
PaCO2NotChg, #
pHNotChg, #
TempNotChg, #
SvO2NotChg, #
SaO2NotChg, #
HighpHGoal, #
HighPaCO2Goal, #
HighTempGoal, #
LowPaCO2Goal, #
Parameter_v2 (3 of 3)
SvO2GoalHigh, #
SaO2GoalHigh, #
NotChg 2=Not changed from previous study day
NotSet99=Not Set
PudID # Occurrence # ItemGroupRepeatKey #
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ECMO Blood Product & Medication Information:
Blood (1 of 2)
PlasmaGiven, #
PRBCAmount, #
WholeBloodAmount, #
PRBCPrime, #
WholeBloodPrime, #
PRBCGiven, #
WholeBloodGiven, #
PlasmaPrime, #
CryoAmount, #
CryoGiven, #
PlateletsAmount, #
PlasmaAmount, #
PlateletsGiven, #
YesNo 1=Yes 0=No
ItemGroupRepeatKey # Occurrence # PudID #
BLOODDAY, #
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ECMO Blood Product & Medication Information:
Blood (2 of 2)
HeparinHeld, #
ATIIIGiven, #
AmicarLoadDose, #AmicarInfusion, #
AmicarGiven, #
HeparinHeldHours, #
ATIIIDose, #
AmicarDose, #
YesNo1=Yes 0=No
YesNo1=Yes 0=No
NovoDose, #
NovoGiven, #
PudID # Occurrence # ItemGroupRepeatKey #
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ECMO Organ Systems:
Organ (1 of 1)
HepaticSystem, #
PulmSystem, #
RenalSystem, #
CardioSystem, #
NeuroSystem, #
YesNo 1=Yes 0=No
ItemGroupRepeatKey # Occurrence # PudID #
ORGANFAILDAY, #