QuikClot Use in Trauma for Hemorrhage Control: Case Seriesof 103 Documented UsesPeter Rhee, MD, MPH, Carlos Brown, MD, Matthew Martin, MD, Ali Salim, MD, Dave Plurad, MD,Donald Green, MD, Lowell Chambers, MD, Demetrios Demetriades, MD, PhD, George Velmahos, MD,and Hassan Alam, MD
Background: Local hemostatics haverecently been introduced for field use tocontrol external hemorrhage. The objec-tive of this report is to describe the initialclinical experience with QuikClot, a zeo-lite that works by absorbing water andconcentrating coagulation factors to stopbleeding in a series of patients.
Methods: Documented cases using aself-reporting survey sheet submitted bythe users and first-hand detailed inter-views with the users when possible.
Results: There were 103 documentedcases of QuikClot use: 69 by the US mili-tary in Iraq, 20 by civilian trauma sur-
geons and 14 by civilian first responders.There were 83 cases involving applicationto external wounds and 20 cases of intra-corporeal use by military and civiliansurgeons. All field applications by first re-sponders were successful in controllinghemorrhage. The overall efficacy rate was92% with eight cases of ineffectivenessnoted by physicians in morbid patientswith massive injuries when the QuikClotwas used as a last resort. These reportedfailures were thought to be a result of thecoagulopathic state of the patient frommassive resuscitation or the inability toget the product directly to the source of
hemorrhage. When the QuikClot was ap-plied on responsive patients, the heat gen-erated by the exothermic reaction causedmild to severe pain and discomfort. Therewere three cases of burns caused by theheat generated by the QuikClot applica-tion with one case requiring skin grafting.There was one major complication fromintracorporeal use caused by scar forma-tion from a foreign body reaction.
Conclusions: QuikClot has been ef-fectively used by a wide range of provid-ers in the field and hospital to controlhemorrhage.
J Trauma. 2008;64:1093–1099.
Whether in the field and or the hospital, expedienthemorrhage control is of paramount importance inmanagement of trauma. The US military has re-
cently developed and tested a number of local hemostaticagents designed to facilitate rapid hemorrhage control.1,2 Oneof these products, approved by the Food and Drug Adminis-tration (FDA) for external use and distributed for use in thebattlefield the US military is a manufactured granular mineralzeolite called QuikClot.3,4 This inert mineral product com-posed of oxides of silicon, aluminum, sodium, and magne-sium and small amounts of quartz. It acts as molecular sieve
and rapidly adsorbs water in a nonchemical, physical reac-tion. Although this process generates heat, the primary mech-anism effecting hemostasis is caused by the absorption ofwater and the rapid concentration of platelets and clottingfactors5 that promotes rapid clot formation. Although thisproduct is being sold and distributed, its clinical use andefficacy has not yet been reported in a case series. This reportdescribes the first 103 documented clinical use of this localhemostat.
METHODSThe data for this report were generated by summarizing
case reports (Fig. 1) that were submitted by the users ofQuikClot or by direct interviews with users. The surveyforms were distributed to individuals that reported use to themanufacturer and through “word of mouth”. Personal inter-views were conducted by the reporting author (P.R.) with theusers who filled out the survey sheets to obtain details of itsuse when possible. Approximately 75% of the users whofilled out the surveys were contacted to discuss the cases.Approximately 30 other known case reports were available atthe time of this report, but they were neither confirmable nordocumented and thus not used for this report. The uses ofQuikClot were not under any study or study protocol. Therewere cases collected from Los Angeles County Medical Cen-ter and the summation of the data from this hospital was withthe approval by the institutional review board.
Arizona; Department of Surgery (C.B.), Brackenridge Hospital, Austin,Texas; Department of Surgery (M.M., D.P., D.G., L.C., D.D.), Los AngelesCounty Medical Center � University of Southern California, Los Angeles,California; Department of Surgery (A.S.), Cedars Sinai, Los Angeles, Cali-fornia; and Department of Surgery, (G.V., H.A.), Massachusetts GeneralHospital, Boston, Massachusetts.
The opinions and assertions contained herein are the private ones of theauthors and are not to be construed as official or reflecting the views of theDepartment of Defense at large. This manuscript was prepared by UnitedStates Government employees and, therefore, cannot be copyrighted and maybe copied with restriction.
Address for reprints: Peter Rhee, MD, MPH, Trauma, Critical Care andEmergency Surgery, University Medical Center, 1501 N. Campbell Ave.,Tucson, AZ 85724; email: [email protected].
DOI: 10.1097/TA.0b013e31812f6dbc
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Fig. 1. Self-reporting survey sheet. Typical report that was submitted.
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RESULTSThe documented users of the QuikClot as a local hemo-
static agent included US military and civilian personnel. USmilitary users were first responders (US Army medics andUS Navy corpsman), as well as medical officers who usedQuikClot during the war in Iraq (Operation Iraqi Freedom).Civilian users were police officers, paramedics, laypersons, andtrauma surgeons. The users and their frequency of QuikClot useare shown in Table 1.
The location of QuikClot application was both externaland intracorporeal as shown on Table 2. Many had multipleapplications and these instances occurred in Iraq by militaryfirst responders. The locations of the QuikClot applicationwere quite varied. Most of the locations were on externalextremity wounds. The majority of its use in the extremitywas after ineffectiveness of direct pressure or tourniquet use.
QuikClot was also applied to areas that tourniquets couldnot be applied to such as the chest wall, back, abdominalwall, groin, buttocks, and shoulder. An example of this sce-nario was an injury to the proximal upper arm. On arrival toa surgical facility, the casualty was hypotensive and wastaken to the operating room. The casualty had a subclavianartery and vein injury, but there were other multiple bleedingsites including the pectoralis, deltoid, and upper arm muscles(Fig. 2). QuikClot was applied to control the bleeding fromthe various sites to allow the surgeons to quickly obtainsurgical control of the subclavian artery that was repaired.Reports of use in the head and neck region included use forsevere scalp lacerations as well as neck and face. One case ofuse in the face included a sailor who was struck by a rotorblade from a helicopter causing multiple injuries (Fig. 3). An
independent duty Navy corpsman applied QuikClot to theface and extremity injuries and transported the patient to acasualty receiving and treatment ship where a surgeon wasavailable. The treating surgeon stated that he thought theQuikClot was effective in controlling the bleeding and waslifesaving. Civilian examples include the use of QuikClot bya fireman to treat the bleeding site of a hemodialysis catheterthat was accidentally pulled out and a police officer whoapplied it to the neck of a self-inflicted slash wound.
Blunt civilian trauma was the mechanism on eight casesand five of these patient uses were for severe scalp lacera-tions. The remaining three injuries from blunt trauma werethe avulsion site of a left diaphragm from the chest wall, bluntliver laceration, and a major laceration of the groin withfemoral neck and pelvic fracture after being stuck by a train.The mechanism of injury and effectiveness of QuikClot areshown in Table 3. There were 22 cases of blast injury fromartillery or improvised explosive devices. The remaining 73indications were from penetrating trauma. The penetratingtrauma cases were mostly military-related injuries includinghigh-velocity gunshot wounds and penetrating fragmentationinjury. Five of the penetrating injuries were from lacerationscaused by knife wounds.
Fig. 2. Casualty with injury to the right shoulder region.
Fig. 3. QuikClot use on the face of a sailor who sustained lacera-tions to face and extremities from a helicopter rotor.
Head/scalp/neck 12Upper or lower extremity 61Chest/Upper back 16Abdomen/back/buttocks/pelvis/groin 18Intra corporeal (chest, abdomen, pelvis) 20
Some patients had multiple uses.
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In the military field setting, pressure dressings wereattempted first, and when they failed, tourniquet use wasattempted on extremities when possible. The current instruc-tion for use in the combat battlefield is for external source ofhemorrhage that is life threatening and uncontrolled by allother means. After ineffectiveness of these measures, Quik-Clot was to be used. When QuikClot was initially distributedwidely to marines and corpsmen, the instructions for use wereon the package. The users included Army medics and Navycorpsman as well as medical officers. The medical officerswere either emergency medicine physicians attached to aforward echelon I facility or general surgeons at a forwardresuscitation surgical facility. The experience from the fieldmedic or corpsman was different from medical officers. Thefield medic or corpsman experience was universally positive,and they all described 100% efficacy. Approximately 25% ofthis type of use reported concomitant mild to severe pain anddiscomfort associated with the exothermic reaction fromQuikClot if the casualty was responsive. None of the medicsor corpsmen thought that QuikClot caused additional injury.They also universally thought that QuikClot was helpful andthat if they were to deploy again, they would definitely useit again.
The reports from the medical officers and trauma sur-geons were different from those of the medics and corpsmanas ineffectiveness to control hemorrhage was noted (Table 4).The reasons for ineffectiveness of hemorrhage control wereuniversally thought to be a result of coagulopathy from hem-orrhage and resuscitation or because QuikClot was not ade-quately delivered directly to the source of hemorrhage such asacetabular or pelvic fractures. Six of the eight patients in
which QuikClot failed to control bleeding were in a moribundstate and died.
Information regarding hypotension from bleeding wasavailable on 80% of the reports and in these patients 85%were “hypotensive” indicating possible life-threateninghemorrhage. Intracorporeal uses numbered 20 (Table 5)and included the thorax, abdomen, and pelvis. The intra-corporeal uses were all by trauma surgeons (Los AngelesCounty Medical Center/Massachusetts General Hospital),and in four cases, it was used in Iraq at a forward resuscitationsurgical site. Intra-abdominal uses were for abdominal wall orretroperitoneal bleeding and pelvic bleeding, but in one instance,it was for severe liver bleeding in a moribund coagulopathicpatient who died.
There were four documented complications in these se-ries. There were three burn cases and one of these casesrequired further wound care that included split thickness skingrafting. The other two cases were mild partial thicknessburns that did not require any further wound management andhealed spontaneously (Fig. 4). In one instance, QuikClot wasplaced into the retroperitoneum after a civilian gunshotwound to the back. This patient returned several months laterwith ureteral obstruction caused by scar formation that mayhave been caused by the foreign body reaction from Quik-
Table 4 Ineffectiveness of QuikClot to ControlHemorrhage
Fig. 4. QuikClot application to a wound in the sacral region withpartial thickness burn to the anal region. This wound only requiredskin care.
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Clot. This patient required resection of the ureter and a psoashitch procure.
DISCUSSIONThis is the first reported series of (QuikClot) use in
humans to control bleeding. The field use by first responders,whether it was in the civilian setting or in the combat setting,was 100% effective. The military field experience was fromeither US Army medics or US Navy corpsman supporting theefforts in the Iraq War. Most uses were in extremities inhypotensive casualties, and all thought that QuikClot wasused in life-threatening injuries. Overall, the efficacy was92% but was caused by the ineffectiveness noted by MedicalOfficers in the field and by trauma surgeons. These ineffec-tive cases were in coagulopathic moribund patients who hadapplication of QuikClot as a last resort. The main reason forthe ineffectiveness seemed to have occurred when QuikClotcould not be applied to the main source of hemorrhage.
The US military is continually searching for the ideallocal hemostatic agent that will control bleeding in the field.Continued research is ongoing to further enhance the cur-rently available products as well as testing many other prod-ucts. Although many products have been tested, to date thereare only two FDA-approved devices at the time of this reportthat are distributed for use in the battlefield. These productsare a chitosan-based dressing (Hemcon) and QuikClot. TheUS Army currently distributes Hemcon and the US Navy andMarines distribute QuikClot. Each service has a separateprocess for choosing and distributing local hemostatics. Thecurrent recommendation for using QuikClot by the US Navyis for life-threatening external hemorrhage that is not control-lable by routine means.6 The Committee for Tactical CombatCasualty Care comprising the four services (US Army, Navy,Air force, Coast Guard) currently recommends the use of apressure dressing, and if this does not control the bleeding, itrecommends to escalate to using Hemcon or QuikClot. Thisguideline can be found in the military module section of theprehospital trauma life-support course.
QuikClot was tested by the US Navy in a porcine modelof severe hemorrhage, which uses a large soft tissue injury tothe groin of a swine, resulting in bleeding from the femoralartery and vein. In this model, QuikClot was found to be themost highly effective method for controlling bleeding andresulted in reduced mortality. This and several other studieshave demonstrated its benefits and potential problems. Al-though seemingly effective in animal models, the main prob-lem is the exothermic reaction that is caused by the QuikClotand this is a potential for tissue injury. There are othernegative attributes of this product that include the fact that thereported version of QuikClot is granular and is similar topouring a coarse sandy material in the wounds. Although thisproduct is sterile, it can be problematic as it is difficult toextract all of the QuikClot out of the wounds and it will causea foreign body reaction. QuikClot is now available in a bagformat so the granules do not freely distribute in the wound
(QuikClot Advanced Clotting Sponge). One of the cases inthis series includes the use of this product, but it failed tocontrol hemorrhage. The reason for its ineffectiveness tocontrol hemorrhage was a result of the inability to get theAdvanced Clotting Sponge directly to the source of hemor-rhage that was from the acetabular and femoral neck fracturecaused by a high-velocity firearm (Fig. 5). QuikClot 1st Re-sponse is also a bagged zeolite that has been reengineered toremain effective while reducing the exothermic reaction andin vivo experiments have shown the maximal temperature tobe only 105°F.7
The use of improvised explosive devices in the militarysetting results in massive tissue loss and contamination (Fig.6). In most circumstances, and the additional contaminationcaused by QuikClot was thought to be a minor overall factor.These injuries are usually irrigated and debrided multipletimes and the wounds are usually left open, so the inability tocompletely remove all of the residual QuikClot has not yetbeen reported to be a major problem. The negative aspects ofthis product are real, but if exsanguination is the alternative,it may be the lesser of the two evils.
The civilian field experience was reported by variousproviders including law enforcement, Emergency MedicalTechnicians or Paramedics, and firemen. Examples of theiruse include application for lacerations from knives, barbedwire fence, glass windows, gunshot wounds to the neck anda hemodialysis catheter dislodgment. In all of these cases,QuikClot was thought to be completely effective in hemor-rhage control. The training and medical experience of thisgroup is unknown but it is probably limited in regards tohemorrhage control. From the description of these uses it wasnot possible to exactly quantify the amount of hemorrhage,but all the reports stated that the bleeding was massive and
Fig. 5. Pelvic roentgenogram of high-velocity gunshot wound to thefemoral head. Bagged QuikClot was applied but failed because ofbony bleeding from the fractures.
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the hemorrhage control was “lifesaving”. It is easily arguablethat not all these cases needed QuikClot for hemorrhagecontrol such as in the case of the hemodialysis catheterdislodgment.
Although QuikClot is only approved for external use bythe FDA and is only recommended for external use by themanufacturer, there were 20 cases of intracorporeal use ofQuikClot. The majority of intracorporeal uses were at LosAngeles County Medical Center by various trauma surgeons.These cases included use in the chest, abdomen, and pelvis.These uses were “off label” and not used in a study protocol.One of the intrathroacic uses has been previously reported inliterature.8 Intrathoracic use in this series includes similarapplications by Navy surgeons in forward surgical systemwhere uncontrolled bleeding was from a thoracic spine andchest wall injury that was refractory to all other surgicalmeans. This casualty was paralyzed from the initial woundingbut survived and did well without complications from theintracorporeal use of QuikClot. An example of its use incivilian blunt trauma was an intrathoracic application forpersistent chest wall bleeding from a large avulsion of theright diaphragm with liver herniation. Despite all conven-tional means to control diffuse bleeding, the area of avulsionhad persistent bleeding. On the third operation within the first24 hours of admission for persistent bleeding, the bleedingwas finally stopped only with the QuikClot application. An-other example of intrathoracic use was the successful appli-cation of QuikClot to the uncontrollable chest wall or sternalbleeding from a gunshot wound. Interestingly, this patientalso had persistent bleeding from a distal coronary laceration.Hemcon, a local hemostatic that is not exothermic was ap-plied to the coronary arterial bleeding. This case illustrates
appropriate uses of different local hemostatics in differentsituations.
Abdominal uses were for gunshot wounds that resultedin uncontrollable gunshot tract bleeding in the retroperitonealregion or pelvis. In three cases, patients bled after an explor-atory celiotomy and persistent rebleeding from the gunshotwound tract in the psoas muscle. These wounds were effec-tively treated with QuikClot. In these cases. After all otherconventional measures such as (electrocautery, gelfoam withthrombin, lap sponge packing) failed, QuikClot stopped thebleeding during the second operation. None of these patientsdeveloped infectious complications even when there was hol-low viscous contamination.
There were eight reported ineffective uses of QuikClot tocontrol bleeding. In each scenario, the patients were hemodi-luted, coagulopathic, and moribund. Because the mechanismof action relies on concentration of innate coagulation factorsin blood, it is not surprising that QuikClot was not effectivein these circumstances. It is also important to note that in thecases when QuikClot was ineffective, it was because thewounds were of a nature such that it was difficult gettingproduct directly on the source of bleeding. This is not nec-essarily an ineffectiveness of the product, as it cannot beexpected to work unless the product is properly delivered tothe source of hemorrhage.
The long-term complications are not fully known fromthis type of report. There is one known casualty that requiredsplit thickness skin grafting. Two other superficial burns havebeen recorded, but they did not require any other therapy. Inthese types of injuries, the application of a sterile granularsubstance would probably be inconsequential given the factthat there is severe contamination. In approximately four
Fig. 6. Type of severe wounds caused by improvised explosive devices with massive contamination. A, arrow points to the deep wound thathad QuikClot application. B, type of wound that QuikClot was used in.
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cases where QuikClot was used for avulsion type lacerationsin the scalp, these wounds were irrigated out and suturerepaired. Although the bleeding was completely controlled,upon irrigation and removal of the QuikClot granules, thescalp lacerations began to bleed. This suggests that QuikClotdid not cause third-degree burns. These wounds did havelong-term follow-up and no complications attributable toQuikClot were noted.
There is one known case of a serious complication fromQuikClot use. It was used in the pelvis for uncontrollablehemorrhage from the sacroiliac joint resulting from a gunshotwound. After ligation of the iliac vein the gunshot woundtract had persistent bleeding despite all other conventionalmeans to stop bleeding. The application of QuikClot imme-diately stopped the bleeding. Long-term follow-up on thispatient demonstrated ureteral obstruction 2 months after theinitial treatment, and on subsequent surgery, it was found thatthe intense foreign body reaction caused scar formation ob-structing the ureter. A psoas hitch to the bladder was per-formed to remedy this complication.
It is important to note that this case series is an accumu-lation of reports submitted by users and thus is not probablyrepresentative of its true use, efficacy, or complications. Ithas to be assumed that as with most new products introduced,most users are willing to provide success stories and it willtake time for the reports of ineffectiveness and complicationsto be accumulated. This report may generate those reports ofineffectiveness. The difference in the ineffectiveness betweenfirst responders and physicians is caused by either a “thresh-old effect” as the corpsman and medics were probably moreeager to use in less severe injuries and may also be a result ofphysicians waiting too long before its use. Because the prod-uct is approved by the FDA and readily available for com-mercial use, it is exceedingly difficult to obtain reports ofeach use whether it is in the civilian sector or the militarysetting. Currently, there are no means to completely collectall experiences of this new device.
In summary, this report is the first series of the clinicalexperience using QuikClot in humans. The overall efficacy
was 92% but the field experience by various providers was100%. The QuikClot is approved for use on uncontrolledexternal hemorrhage but there have been 20 cases of intra-corporeal use for uncontrollable life-threatening hemorrhagethat was not amendable to conventional therapy. Ineffective-ness of QuikClot has been reported in coagulopathic patientswhere it was thought that QuikClot could not be applieddirectly to the bleeding source. Although some complicationshave been reported, its ultimate complication rate is not yetfully known. As with any tool available for medical use, thereare appropriate circumstances where it is useful and circum-stances where it is not. Obtaining training before use wouldbe preferred whenever possible.
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