DTIC ADA614759: Point-of-injury Use of Reconstituted Freeze Dried Plasma as a Resuscitative Fluid: A Special Report for Prehospital Trauma Care

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by  Defense Technical Information Center

SPECIAL REPORT
Point-of-injury use of reconstituted freeze dried plasma as a
resuscitative fluid: A special report for prehospital trauma care
Elon Glassberg, MD, MHA, Roy Nadler, MD, Todd E. Rasmussen, MD, Amir Abramovich, MD, MPH,
Tomer Erlich, MD, Lorne H. Blackbourne, MD, and Yitshak Kreiss, MD, MPA, MHA, Ramat Gan, Israel
This special report describes the broader implications of resuscitation has been established to limit overuse of poten-
prehospital fluid resuscitation in the context of what is tially harmful balanced salt solutions such as normal saline,
the first reported case of point-of-injury use of reconstituted, lactated Ringer’s solution, and even colloids3 In a paradigm
lyophilized single-donor freeze dried plasma (FDP) as a re- shift,medicsnowlimittheuseofthesesolutions,whichmay
suscitativefluid. raise a trauma victim’s blood pressure and cause dilution of
TheIsraeliDefenseForceMedicalCorps(IDF-MC)has clottingfactors,whichtogethermayworsenbleeding.
deployedFDPasanotherstepintheevolutionofcasualtycare Theseandotheradvanceshaveresultedinlivessavedin
tobringdamage-controlresuscitationclosertothepointof in- the prehospital setting. However, the most significant break-
jury as part of the multidisciplinary efforts to improve trauma through in contemporary trauma care, relating to the selec-
victims’outcome. tive infusion of the components of whole blood, has yet to
be made available for routine prehospital use. The singular
BACKGROUND burdenof injuryfromthewarsofthelastdecadehaslaidbare
the importance of death from hemorrhage, most commonly
Trauma is the leading cause of death among adults be-
noncompressibletruncalhemorrhage,andledtoareappraisal
tween the ages 18 years and 40 years and the second most
ofdogmapertainingtotypesofprehospitalfluidresuscitation.
expensivepublichealthproblemintheUnitedStatesaheadof
Largelybecauseofrecentmilitarytraumaresearch,theuseof
cancer,mentalillness,anddiabetes.1Managingtheburdenof
packed red blood cells, plasma, and platelets in the prehospi-
injuriesfromdecadesofwarshasunderscoredtheimportance
talsettingforpatientshavingsustainedsevereinjuryhasbeen
oftraumaresearchaimedatreducingmorbidityandmortality.
pursued.
Seminalreportsfromthisresearchhaveshownthatmorethan
The beneficial effect of fresh whole blood as a resusci-
80%ofdeaths onthebattlefield occur before patients reach a
tativefluidtoexpandapatient’scirculatoryvolumefollowing
medical treatment facility. Furthermore, one in four of these
traumaandshockhasbeenobservedformorethanacentury.4
‘‘prehospital deaths’’ have been shown to be potentially sur-
In addition to restoring circulatory volume, whole blood pro-
vivable, with improved strategies of patient care at the point
vides oxygen carrying capacity, vitally important clotting fac-
of injury anden route toa treatmentfacility.2
tors, platelets, and a buffering capability. Impracticality and
To date, most advances in prehospital care of dying
safetyissueshaveledtoadisassemblyofwholebloodintoits
trauma patients have been aimed at maneuvers to control
components to allow storage, shipment, safety assurance, and
bleedingatthesceneorenroutetoahospital.Combatcasualty
selective or targeted transfusion. In fact, one of the most sig-
careresearchintheUnitedStatesandinternationallyhasdem-
nificant lessons stemming from the wars in Afghanistan and
onstrated the lifesaving effectiveness of tourniquets to control
Iraq has been that life saving was associated with balanced,
hemorrhage in certain patterns of extremity trauma.2 Topical
component-based resuscitation, namely, platelets, plasma, and
agents or bandages have also been developed for application
packed red blood cells,5 in what is effectively a reassembly of
by providers at the point of injury to control bleeding from
thewholeblood.6
open wounds. The concept of low-volume or hemostatic
Coagulopathy induced by trauma develops in 20% to
30% of combat casualties requiring blood transfusion, with
KEYWORDS: Plasma;freezedriedplasma;prehospital;pointofinjurycare;
a rise in prevalence with increasing injury severity,7 and is
resuscitationfluid;traumainducedcoagulopathy.
associated independently with an up to a fivefold increase in
mortality.6,8,9Rapidandaggressivetreatmentofcoagulopathy
Submitted:March28,2013,Revised:April10,2013,Accepted:May1,2013. induced by trauma (including prompt transfusion of plasma
From the Surgeon General Headquarters (E.G., R.N., A.A., T.E., Y.K.), Israel
andplatelets)wasshowntoreducemortalityinhemorrhaging
DefenseForces,RamatGan,Israel;DepartmentofMilitaryMedicine(E.G.,
R.N.,A.A.,T.E.,Y.K.),HebrewUniversity,Jerusalem,Israel;andUSArmy patients,10,11 therefore representing a major challenge for
Institute of Surgical Research (T.E.R.), Joint Base Fort Sam Houston, San point-of-injury/combat casualty care phase, as recognized by
Antonio,Texas;TheNormanM.RichDepartmentofSurgery(T.E.R.),The providersaround theworld.12,13
UniformedServicesUniversityoftheHealthSciences,Bethesda,Maryland;and
Plasma infusion is considered to be the standard of care
USArmyTraumaTrainingCenter(L.H.B.),Miami,Florida.
Addressforreprints:ElonGlassberg,MD,MHA,MedicalCorps,SurgeonGen- for treating trauma-induced coagulopathy. Plasma has demon-
eral’sHeadquarters,MilitaryPOB02149,IsraelDefenseForce,Israel;email: stratedsuperiorityovercolloidfluidsatreversingcoagulopathy
[email protected].
secondarytotraumaandimprovingsurvivalinanimalmodels,
DOI:10.1097/TA.0b013e318299d217 evenwithouttransfusingredbloodcells.13Y15Furthermore,high
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4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER
Point-of-injury use of reconstituted freeze dried plasma as a resuscitative
5b. GRANT NUMBER
fluid: A special report for prehospital trauma care
5c. PROGRAM ELEMENT NUMBER
6. AUTHOR(S) 5d. PROJECT NUMBER
Glassberg E., Nadler R., Rasmussen T. E., Abramovich A., Erlich T.,
5e. TASK NUMBER
Blackbourne L. H., Kreiss Y.,
5f. WORK UNIT NUMBER
7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) 8. PERFORMING ORGANIZATION
United States Army Institute of Surgical Research, JBSA Fort Sam REPORT NUMBER
Houston, TX
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JTraumaAcuteCareSurg
Glassbergetal. Volume75,Number2,Supplement2
plasmaYtoYred blood cell (RBC) ratio was found to be corre- (i.e., use as primary resuscitation fluid) plasma use has not
lated with improved survival in trauma patients, with ratios beenreportedsincethe1950s,andpoint-of-injurysingle-donor
approaching1:1demonstratingthemostprominenteffect.10,16,17 plasmawas notpreviously reported.
This effect is further emphasized in the subgroup of patients Modern data exist regarding the use of dried plasma,
requiringmassivetransfusion(definedastheinfusionof 910U including invitro data, animal model, as well as clinical data
of blood in 24 hours).18 Early administration of fresh frozen concerning its qualities and efficacy compared with that of
plasma(FFP)wasassociatedwithincreasedsurvival,aneffect fresh plasma and FFP. In vitro analysis of FDP has demon-
diminished with delayed infusion, as demonstrated in a pro- strated a decrease of factor Vand VIII by 80% and 75%, re-
spective study.10,17 Recentstudies have alsodemonstrated that spectively, when compared with fresh plasma. However, the
the use of plasma in the prehospital setting, compared with global capacity to induce clot formation in vitro was shown
control,wasassociatedwithsignificantimprovementinthein- tobepreserved.29SeveralanimalmodelscomparingFFPand
ternationalnormalizedratioonarrival,lowervolumeofcrystal- FDP have not demonstrated any differencewith respect to co-
loid infusion, and elimination of plasma deficit at 24 hours.19 agulation parameters,30,31 and some have demonstrated a co-
The rapid availability of plasma is thus of increasing impor- agulationprofilesimilartothatoffreshplasmaandsuperiorto
tance.10,20 It is important to note that some of the advantages the coagulation profile of FFP.32 Several authors have already
offered by the plasma are not fully understood at this time.21 advocatedtheuseofdriedplasmainthebattlefieldasthenext
Unfortunately, FFP is not available in the prehospital setting, generationofdamage-controlresuscitation.12,13,33
owing to the necessity to store the plasma at j18-C to maxi- As of now, owing to the years that have passed since
mizeitsshelflife,mandatingathawingprocessthatrequires the use of FDP by US providers, the Food and Drug Admin-
both equipment not available in the field and approximately istration now requires reevaluation of the Food and Drug
30minutestocomplete. AdministrationbeforeapprovingitsuseintheUnitedStates.34
FDP, introduced in 1941, offers potential to serve as a The IDF-MC has embraced the concept of eliminating
resuscitationfluidinthefield,requiringnorefrigeration,simple, preventable deaths as part of the next 10-year force build-up
andsafe.UsedinthebattlefieldsoftheWorldWarIIandKorea, plan and emphasizes point-of-injury care. As most trauma
earlydriedplasmawaspooledfromasmanyas1,000donors,in- deathsoccurintheprehospitalsettingandinthefirsthourafter
troducingasubstantialriskforablood-borninfections.22 injury,thisiswheremostlivescanbesaved.2
FDP usewas subsequently abandoned by the US blood These efforts include deploying advanced lifesavers to
bank owing to the risk of hepatitis,22 with the thought being the front lines; the use of effective tourniquets; resuscitation
that with the introduction of helicopters and shorter evacua- fluids that ameliorate the trauma-induced coagulopathy and
tion times, the need for field resuscitation will diminish in a acidosis; haemostatic agents and more, along with constant
way that will not justify the risks involved in the plasma ad- feedback from rapid and professional investigations of inci-
ministration. Production continued in France, and during the dentsinvolvingcasualtycare;aswellasadetailedtraumaregistry
Indochinawar(1946Y1979),almost40,000Uofdriedplasma and goal-directed research efforts, to found the basis for our
wasproduced bythe French Military Blood Institute.23 clinicalpracticeguidelines.
The German Red Cross produces a similar freeze dried Included in the attempts to optimize the care provided
andlyophilizedplasma,collectedfromasingledonor,offering to the wounded before reaching the advanced care facilities
an even more improved safety profile owing to a quarantine (whetherciviliantraumacentersordeployedmilitarymedical
periodof 4 months and ashelf life of15 months. units),greatemphasisisonapplyingdamage-controlresuscita-
Risks commonly associated with plasma transfusion tion principles that call for limiting intravascular volume re-
(as with other blood products) include transfusion-associated placementtotheminimumrequiredtoperfusevitalorgansand
lung injury, allergic transfusion reactions, and transfusion- theuseofbloodproductsfor resuscitation,aspartour resusci-
associated volume overload, which are more common with tation protocols. Thus, IDF-MC advanced lifesavers (physi-
massive transfusions of ABO-incompatible plasma.24Y26 Less cian and EMT paramedics) limit the volume of crystalloids
commonrisksareinfectiousdiseasetransmission,whiteblood administeredandcarrytranexamicacid(TXA).3,35
cellYassociatedrisk,andalloimmunization-relatedrisks.24Itis AsofJanuary2013,FDPwasintroducedtotheIDF-MC
worthnotingthat todate,allreportsregardingmajoradverse astheadvancedresuscitationfluidfortraumacasualties,under
reactionswererelatedeithertotheuseoffreshplasmaorFFP. a protocol developed by the Trauma and Combat Medicine
The French Hemoviligance system has recorded more than Branch of the IDF-MC, with the help of leading trauma and
1,000 administrations of dried plasma, with no documenta- hematology experts, both in Israel and in the United States.
tionofanysignificantadverseeffect.23TheGermanRedCross The FDP, whichevery physician and paramedic in the IDFis
reports the cumulative use of several hundred thousand equipped with, is meant to serve forth and for all as a resus-
units, with no major adverse effects attributed to the FDP citation fluid, avolume expander, excellentbufferingcapacity,
recorded.13,27Thisimprovedsafetyprofileisprobablyrelated and a sourcefor coagulation factors,takingintoaccount some
totheremovalofresidualcellsthroughfiltrationandusingonly obviousadvantagessuchasbeinginitiallypHbalanced(unlike
those that come from male donors or those examined for the saline or lactated Ringer’s solutions with a pH of 5.4 and
leukocyteantibodies. 6.2,respectively).
Recently, French-made FDP has been used for taking TheproductchosenbytheIDF-MCwasLyoPlas(DRK-
care of wounded soldiers admitted to intensive care units in Blutspendedienst West, German Red Cross) owing to the
Afghanistan.28 To the best of our knowledge, point-of-injury qualitiesmentionedpreviously,theimprovedsafetyindexand
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JTraumaAcuteCareSurg
Volume75,Number2,Supplement2 Glassbergetal.
record,thesimpleandrapidreconstitutionprocess,alongwith (1:1:1ofpackedRBCs,plasma,andplatelets),whichhasbeen
the advantageof its being a commercial product storedatam- shown to carry asurvival benefit.16
bienttemperateof2-Cto25-C.Thereconstitutionprocessin- To the best of our knowledge, this special report is the
volvesinfusionofthesuppliedwaterforinjectionviaasupplied firstandonlydocumenteduseofsingle-donorFDPatthepoint
transfersettothebottlecontainingthepowderedplasma,which of injury. The case demonstrates the possibility of overtreat-
completely dissolveswithin a few minutes. Transfusion of the mentandtheneedforbettermonitoringsystemsfordiagnosing
plasmathentakesplacethrougha170-Hmto230-Hmstandard shockandguidingprehospitalresuscitation.Injurypatternsand
filter.TheuseoftypeABmaleorthoseexaminedforleukocyte modelingwithvitalsignswillhelpguideplasmatherapyinthe
antibodiesensurestheproducttobesuitableforallbloodtypes. short term. As experience with FDP administration continues
toaccumulatewithintheIDF-MCandothersaroundtheworld,
The First Use of FDP at the Point of Injury lessonslearnedandafter-actionreportsmayhelptoupdateand
tune our clinical practice guidelines for FDP administration,
An IDF paramedic responded to the scene of a motor
asneeded.
vehiclecrash,whichinjuredanindividualwhosustainedsevere
This landmark case described here is not the trigger to
blunt abdominal, pelvic, and head trauma (Glasgow Coma
changepoliciesbutrathertodescribeoureffortstoimplement
Scale[GCS]of8).Thepatienthadasystolicbloodpressureof
new modalities of therapy in the prehospital settings and gen-
80mmHgandaheartrateof110beatsperminute.Morethan
erate hypotheses for trauma research. It is another important
an hour drive from the nearest hospital, the team of first re-
step in the continuous effort to improve prehospital resuscita-
sponders called for rotary wing evacuation and began resus-
tionparadigmbyfocusingonforwardingrelevanttechnologies
citation efforts while awaiting the arrival of the evacuation
establishedinfixedmedicalfacilitiestothepointof injury,es-
platform. Interventions included orotracheal intubation, place-
peciallythosecopingwithhemorrhagecontrol.Inthisreport,we
mentoftwoperipheralintravenouslines,andTXAadministra-
shedsomelightonaninternationalcollaborationprocessamong
tion.FDP(distributedasapowder)wasreconstitutedandthen
UnitedStates,Israel,andothers,aimedtoaltertheoutcomeina
administeredastheresuscitationfluid.Within30minutesofthe
structuredtraumacaresystemintermsofsafetyandefficacyas
first responders’ arrival, the patient was airlifted to the nearest
occurred with other clinical practice guidelines constructed as
traumacenter(25-minuteflight),sedated,andventilatedwitha
ajointeffort,suchasfortheuseofTXA.Thiseffortneedsfurther
bloodpressureof110/80.
study, and it is our hope that this special report will form the
Uponarrivaltothetraumacenter,94minutesafterinjury,
foundation for future clinical experience and case series. It is
thecasualtywasadmittedtothetraumaintensivecareunit.Ad-
highly probablethatfutureadvances,whichare currently hap-
missionheartratewas86,bloodpressurewas140/100,saturation
pening,willaffectthewaytraumapatientsaretreated.Itisour
was100%.Emergencydepartmentcomputedtomographydem-
view that in trauma patients experiencing extensive hemor-
onstrated a bilateral ischial open pelvic fractures, vertebrae
rhage,plasmashouldbetheresuscitationfluidofchoice,inboth
(L3,L4)compression fractures,andperinealhematoma. Brain
militaryandcivilianscenarios,bothinruralandinurbanpoint-
tomography result was normal. The patient’s admission he-
of-injurycare,thusofferingpotentialforincreasingthesurvival
moglobin was 13.7 g/dL, platelets count of 267 K, lactate of
3.74mmol/L(range,0.5Y2.4mmol/L),internationalnormalized ofcasualtiesandsavinglivesaroundtheworld.
ratioof1.11,andpHlevelof7.34.Thepatient(withanInjury
AUTHORSHIP
SeverityScore[ISS]of22)didnotrequiresubsequentblood
product administration or surgical intervention. After an un- E.G. drafted the paper. All authors have contributed significantly to
articlepreparation,literaturereview,dataacquisitionandinterpretation
complicated course of observation in the intensive care unit,
andcriticalrevisionofthemanuscript.
the patient was extubated within 12 hours and was eventually
transferredtoasecondaryhospital,walkingandunderantibiotic
DISCLOSURE
therapy.
Theauthorsdeclarenoconflictsofinterest.
DISCUSSION
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