Public Use Dataset Annotated eCRF - CPCCRN · 2018. 2. 16. · Public Use Dataset Annotated eCRF...

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

BATE Annotated eCRF

BATE Annotated eCRF_v1.0_16Feb2016 Page 2 of 72

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

BATE Annotated eCRF


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

BATE Annotated eCRF


ECMO Eligibility:

Eligibility (1 of 1)

Inclusion1, #

Inclusion2, #

Inclusion3, #

YesNo1=Yes 0=No

PtEligible, #

Exclusion1, #

YesNo1=Yes 0=No

PudID # ItemGroupRepeatKey # Occurrence #

ScreenDay, #

BATE Annotated eCRF


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, #

BATE Annotated eCRF


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


PrimaryDxOther, $

BATE Annotated eCRF


ECMO Technology Dependence:

TechDepend (1 of 1)

Gastrostomy, #

OtherFeedTube, #

Oxygen, #

Tracheostomy, #

HomeVent, #

VentricularShunt, #

Dialysis, #

VascularAccess, #

YesNo 1=Yes 0=No


BATE Annotated eCRF


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, #


ICUADMITDAY, #

ICUDISDAY, #

HOSPDISDAY, #

DEATHDAY, #

BATE Annotated eCRF


ECMO Physical Measurements:

PM (1 of 1)

Height, # Weight, #

HeadCirc, # HeadCircND, #

NotDoc94=Head circumference not documented


BATE Annotated eCRF


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

BATE Annotated eCRF


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, #


BATE Annotated eCRF


ECMO Baseline Complete Blood Count w/o diff:

BaseCBC (1 of 1)

WBC, # Platelet, # HCTPct, # HgbMass, #CBCNoDiffTime, $

ItemGroupRepeatKey # Occurrence # PudID #

CBCNODIFFDAY, #

BATE Annotated eCRF


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, #


BATE Annotated eCRF


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, #


BMPDAY, #

BATE Annotated eCRF



LDH, # ALT, # AST, # ALP, # TotalBilirubin, # ChemTimeOne, $

BaseChemOne (1 of 1)


CHEMDAYONE, #

BATE Annotated eCRF



Calciummg, # TotalProtein, # LactateUnit, #

Albumin, # ChemTimeTwo, $ Lactate, #

Lactate1=mg/dL 2=mmol/L

BaseChemTwo (1 of 1)


CHEMDAYTWO, #

BATE Annotated eCRF


ECMO Baseline Coagulation Labs:

BaseCoag (1 of 1)

CoagTime, $ PT, # PTT, # INR, # COAGDAY, #


BATE Annotated eCRF


ECMO Baseline Coagulation Labs:

OtherCoagTime, $ Fibrinogen, #

FibrinogenUnit, #

ACT, # ATIIICoag, # AntiXa, #

fib1=mg/dL 2=ng/mL

BaseOtherCoag (1 of 1)


OTHERCOAGDAY, #

BATE Annotated eCRF


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


BASEFUNGALINFECTDAY, #

BASEVIRALINFECTDAY, #

BATE Annotated eCRF


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


VISDAY, #

BATE Annotated eCRF


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, #


BATE Annotated eCRF


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


StudyEvent, $

PCPCDAY, #

FSSDAY, #

BATE Annotated eCRF


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, #


OPPROCEDUREDAY, #

CPBDAY, #

BATE Annotated eCRF


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)


BATE Annotated eCRF


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


FIRSTACTDAY, #

HEPARINAFTERECMODAY, #

BATE Annotated eCRF


ECMO Heparin Units for Circuit Priming:

HeparinPrime (1 of 1)

HeparinPrimingUnits, #


HEPARINUNITDAY, #

BATE Annotated eCRF


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)


CANNULASTARTDAY, #

CANNULASTOPDAY, #

BATE Annotated eCRF


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


VENOUSCANPLACEDAY, # VENOUSCANREMOVEDAY, #

BATE Annotated eCRF



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)


ARTERIALCANREMOVEDAY, #

ARTERIALCANPLACEDAY, #

BATE Annotated eCRF



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, #


DLCCANPLACEDAY, #

BATE Annotated eCRF



Cannulation_Cephalad_v2 (1 of 1)

CephaladCanPlaceTime, $ CephaladCanRemoveTime, $ CEPHALADCANREMOVEDAY, #


CEPHALADCANPLACEDAY, #

BATE Annotated eCRF



Cannulation_LAD_v2 (1 of 1)

LADCanPlaceTime, $ LADCanRemoveTime, $ LADCANPLACEDAY, #


LADCANREMOVEDAY, #

BATE Annotated eCRF



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, #


DPCCANREMOVEEDAY, #

BATE Annotated eCRF


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


STUDYDAY, #

NEWINFECTDAY, #

BATE Annotated eCRF



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


BATE Annotated eCRF



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

BATE Annotated eCRF



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


BATE Annotated eCRF



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 #

BATE Annotated eCRF



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


BATE Annotated eCRF



ECMODaily (7 of 8)

CircuitChgBladderTwo, #

CircuitChgCVVHTwo, #

CircuitChgCompTwo, #

CircuitChgCompSpecifyTwo, #

CircuitChgTubeTwo, # CircuitChgOthCircuitTwo, #

CircuitChgArterialCanTwo, #

CircuitChgOxygenTwo, #

CircuitChgVenousCanTwo, #

CircuitChgPumpTwo, #

CircuitChgHemofilterTwo, #

CircuitChgBridgeTwo, #


YesNo1=Yes 0=No

YesNo 1=Yes 0=No


BATE Annotated eCRF



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


PFHDAY, #

SVO2DAY, #

BATE Annotated eCRF



ECMODaily_v2 (1 of 8)

NewInfect, #

NewInfectTime, $

RemovedFromECMO, #

YesNo1=Yes 0=No

ECMODaily_Infect


STUDYDAY, #

NEWINFECTDAY, # Value not provided

BATE Annotated eCRF




LabSampleLoss, #

ChestTubeOutput, #



SurgicalSiteLoss, #

CannulaSiteLoss, #

PulmBleed, #



GUBleed, #



LabSampleLossND, #

NoCT1=No chest tube


YesNo 1=Yes 0=No


BATE Annotated eCRF




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


BATE Annotated eCRF





ThromClotCVVHOne, #


ThromClotTubeOne, #


ThromClotPumpOne, #
















YesNo1=Yes 0=No

YesNo1=Yes 0=No

YesNo 1=Yes 0=No


BATE Annotated eCRF


















YesNo1=Yes 0=No

YesNo 1=Yes 0=No


BATE Annotated eCRF





ThromClotPumpTwo, #




ThromClotTubeTwo, #


ThromClotCVVHTwo, #





YesNo1=Yes 0=No

YesNo 1=Yes 0=No


BATE Annotated eCRF
















YesNo1=Yes 0=No

YesNo 1=Yes 0=No


BATE Annotated eCRF



PFHTime, $


RequireCVVH, #

ClampedTube, #

FlowRateUnit, #

SvO2Site, #

FlowRate, #

SvO2, #

SvO2Time, $

SvO2ND, #


RequirePlasma, #

YesNo1=Yes 0=No


NotDone95=Not done




PFHDAY, #

SVO2DAY, #

BATE Annotated eCRF




NewInfect, #

NewInfectTime, $

RemovedFromECMO, #

YesNo1=Yes 0=No

ECMODaily_Infect

Value not providedNEWINFECTDAY, #

STUDYDAY, #


BATE Annotated eCRF




LabSampleLoss, #

ChestTubeOutput, #



SurgicalSiteLoss, #

CannulaSiteLoss, #

PulmBleed, #



GUBleed, #



LabSampleLossND, #

NoCT1=No chest tube


YesNo 1=Yes 0=No


BATE Annotated eCRF




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, #


BATE Annotated eCRF





ThromClotCVVHOne, #


ThromClotTubeOne, #


ThromClotPumpOne, #
















YesNo1=Yes 0=No

YesNo1=Yes 0=No

YesNo 1=Yes 0=No


BATE Annotated eCRF



ECMODaily_v3 (5 of 18















YesNo1=Yes 0=No

YesNo 1=Yes 0=No


BATE Annotated eCRF





ThromClotPumpTwo, #




ThromClotTubeTwo, #


ThromClotCVVHTwo, #





YesNo1=Yes 0=No

YesNo 1=Yes 0=No


BATE Annotated eCRF
















YesNo1=Yes 0=No

YesNo 1=Yes 0=No


BATE Annotated eCRF



PFHTime, $


RequireCVVH, #

ClampedTube, #

FlowRateUnit, #

SvO2Site, #

FlowRate, #

SvO2, #

SvO2Time, $

SvO2ND, #


RequirePlasma, #

YesNo1=Yes 0=No


NotDone95=Not done




PFHDAY, #

SVO2DAY, #

BATE Annotated eCRF


ECMO Total Heparin Dose per Day:

HeparinTotal (1 of 1)

TotalHeparinDose, #


TOTALHEPARINDAY, #

BATE Annotated eCRF


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


VENTDAY, #

BATE Annotated eCRF


ECMO Complete Blood Count w/o diff:

CBC (1 of 1)

HgbMass, # HCTPct, # Platelet, # WBC, # CBCNoDiffTime, $

CBC_CBC

CBCNODIFFDAY, #


BATE Annotated eCRF


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 #


BATE Annotated eCRF


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, #


BATE Annotated eCRF


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, #


BATE Annotated eCRF


BATE Annotated eCRF


ECMO Coagulation Labs:

Coag (1 of 2)

INR, # PTT, # PT, # CoagTime, $

Coag_Coag


COAGDAY, #

BATE Annotated eCRF


ECMO Coagulation Labs:

Coag (2 of 2)

FibrinogenUnit, #

Fibrinogen, # OtherCoagTime, $ ACT, # ATIIICoag, # AntiXa, #

fib 1=mg/dL 2=ng/mL

Coag_OtherCoag

OTHERCOAGDAY, #


BATE Annotated eCRF


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)


GOALSDAY, #

BATE Annotated eCRF




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


HighAntiXaGoal, #

HighACTGoal, #

FibrinogenGoalHigh, #

ATIIIGoalHigh, #

PaO2GoalHigh, #


BATE Annotated eCRF



LowpHGoal, #

LowTempGoal, #

SvO2GoalLow, #

SaO2GoalLow, #

PaCO2NotDone, #

pHNotDone, #

TempNotDone, #

SvO2NotDone, #

SaO2NotDone, #

PaCO2NotChg, #

pHNotChg, #

TempNotChg, #

SvO2NotChg, #

SaO2NotChg, #

HighpHGoal, #

HighPaCO2Goal, #

HighTempGoal, #

LowPaCO2Goal, #


SvO2GoalHigh, #

SaO2GoalHigh, #


NotSet99=Not Set


BATE Annotated eCRF


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


BLOODDAY, #

BATE Annotated eCRF


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, #


BATE Annotated eCRF


ECMO Organ Systems:

Organ (1 of 1)

HepaticSystem, #

PulmSystem, #

RenalSystem, #

CardioSystem, #

NeuroSystem, #

YesNo 1=Yes 0=No


ORGANFAILDAY, #

Date post:	29-Jan-2021
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Public Use Dataset Annotated eCRF - CPCCRN · 2018. 2. 16. · Public Use Dataset Annotated eCRF...

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