Patients. Clinical Trial Haukeland University Hospital...

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Update on Cold vs Warm Stored Platelets in Bleeding CT Surgery

Patients. ClinicalTrialHaukelandUniversityHospital

Bergen

GEIRSTRANDENES,MD,NORNAVSOCTHORNETWORK.SOLSTRAND22JUNI2016

COLDSTOREDPLATELETCLINICALTRIAL

•  Studyoutline:Atwo-armedrandomizedpilotstudywasdesignedtoevaluateifleukoreducedapheresisplateletsinPASstoredforupto7dayscold(4CPLT)oratroomtemperature(RTPLT)areequallyeffec[veintreatmentofpostopera[vebleedinginpa[entsundergoingmajorcardiothoracicsurgery.

•  Complexcardiacsurgerylikelytorequireplatelettransfusion.

HYPOTHESIS

•  Coldstoredapheresisplateletsareassafeandefficaciousasroomtemperaturestoredplatelets(aspartoftransfusionstrategyforbleedingpa[ents)

PRIMARYANDSECONDARYOBJECTIVES

•  P:Tocomparechangeinplateletfunc[onandcoagula[onprofilethefirst24hours

•  S:Chestdrainoutput(postopbleeding)•  S:Totalamountofbloodproductstransfused•  S:Adverseevents–transfusionreac[ons,tromboembolicevents

PATIENTPOPULATION

•  Complexcardiacsurgerywithexpectedlongextracorporal[me(>120minutes)

•  Likelytorequireplatelettransfusion•  Typicalaor[carchsurgerydeephypothermia,endocardi[s,redos,doublevalves,dualplateletinhibi[onnotwithdrawnlast48hoursetc

•  Elec[ve/semielec[vesurgeryonly

INCLUDEDSINCESTARTMIDAPRIL2015

•  65pa[entsenrolledinthestudy•  30pa[entsreceivedplatelettransfusion•  Clusterrandomisa[on

THOR - TRAUMA HEMOSTASIS & OXYGENATION RESEARCH NETWORK

Differenceinmul[plateagertransfusionepisode1

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THOR - TRAUMA HEMOSTASIS & OXYGENATION RESEARCH NETWORK

Plateletcountthefirst24hours

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baseline pretransfusion poshransfusion 24hours

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THOR - TRAUMA HEMOSTASIS & OXYGENATION RESEARCH NETWORK

CHESTDRAINOUTPUT24HOURS

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AVERAGENUMBEROFPLATELETUNITSUSED

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THOR - TRAUMA HEMOSTASIS & OXYGENATION RESEARCH NETWORK

ADVERSEEFFECTSDUETOTRANSFUSIONOFCOLDPLT`S??

•  NOTROMBOEMBOLICEVENTSFIRST24HOURS

THOR - TRAUMA HEMOSTASIS & OXYGENATION RESEARCH NETWORK

THEWAYFORWARD

•  ENDTHISSTUDYWHEN20INEACHARM•  PROCEEDWITHUPTO14DAYSOFCOLDSTORAGENONAGITATED

•  COMPARE1:1:1USINGCOLDSTOREDAPHERESISPLT`SANDCOLDSTOREDWHOLEBLOOD

•  STARTUSINGCOLDSTOREDWHOLEBLOODINTHETRAUMAPACKSSTARTINGSEPTEMBER??