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Page 1: Patients. Clinical Trial Haukeland University Hospital …rdcr.org/wp-content/uploads/2016/07/11-Strandenes-Cold-platelets.pdf · Patients. Clinical Trial Haukeland University Hospital

Disclosures

Page 2: Patients. Clinical Trial Haukeland University Hospital …rdcr.org/wp-content/uploads/2016/07/11-Strandenes-Cold-platelets.pdf · Patients. Clinical Trial Haukeland University Hospital

RDCR.org

Update on Cold vs Warm Stored Platelets in Bleeding CT Surgery

Patients. ClinicalTrialHaukelandUniversityHospital

Bergen

GEIRSTRANDENES,MD,NORNAVSOCTHORNETWORK.SOLSTRAND22JUNI2016

Page 3: Patients. Clinical Trial Haukeland University Hospital …rdcr.org/wp-content/uploads/2016/07/11-Strandenes-Cold-platelets.pdf · Patients. Clinical Trial Haukeland University Hospital

COLDSTOREDPLATELETCLINICALTRIAL

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

•  Complexcardiacsurgerylikelytorequireplatelettransfusion.

Page 4: Patients. Clinical Trial Haukeland University Hospital …rdcr.org/wp-content/uploads/2016/07/11-Strandenes-Cold-platelets.pdf · Patients. Clinical Trial Haukeland University Hospital

HYPOTHESIS

•  Coldstoredapheresisplateletsareassafeandefficaciousasroomtemperaturestoredplatelets(aspartoftransfusionstrategyforbleedingpa[ents)

Page 5: Patients. Clinical Trial Haukeland University Hospital …rdcr.org/wp-content/uploads/2016/07/11-Strandenes-Cold-platelets.pdf · Patients. Clinical Trial Haukeland University Hospital

PRIMARYANDSECONDARYOBJECTIVES

•  P:Tocomparechangeinplateletfunc[onandcoagula[onprofilethefirst24hours

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

Page 6: Patients. Clinical Trial Haukeland University Hospital …rdcr.org/wp-content/uploads/2016/07/11-Strandenes-Cold-platelets.pdf · Patients. Clinical Trial Haukeland University Hospital

PATIENTPOPULATION

•  Complexcardiacsurgerywithexpectedlongextracorporal[me(>120minutes)

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

•  Elec[ve/semielec[vesurgeryonly

Page 7: Patients. Clinical Trial Haukeland University Hospital …rdcr.org/wp-content/uploads/2016/07/11-Strandenes-Cold-platelets.pdf · Patients. Clinical Trial Haukeland University Hospital

INCLUDEDSINCESTARTMIDAPRIL2015

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

Page 8: Patients. Clinical Trial Haukeland University Hospital …rdcr.org/wp-content/uploads/2016/07/11-Strandenes-Cold-platelets.pdf · Patients. Clinical Trial Haukeland University Hospital

THOR - TRAUMA HEMOSTASIS & OXYGENATION RESEARCH NETWORK

Differenceinmul[plateagertransfusionepisode1

0

5

10

15

20

25

30

35

40

trap adp aspi col ristoh

ChartTitle

warm cold

Page 9: Patients. Clinical Trial Haukeland University Hospital …rdcr.org/wp-content/uploads/2016/07/11-Strandenes-Cold-platelets.pdf · Patients. Clinical Trial Haukeland University Hospital

THOR - TRAUMA HEMOSTASIS & OXYGENATION RESEARCH NETWORK

Plateletcountthefirst24hours

0

50

100

150

200

250

baseline pretransfusion poshransfusion 24hours

ChartTitle

Serie1 Serie2

Page 10: Patients. Clinical Trial Haukeland University Hospital …rdcr.org/wp-content/uploads/2016/07/11-Strandenes-Cold-platelets.pdf · Patients. Clinical Trial Haukeland University Hospital

THOR - TRAUMA HEMOSTASIS & OXYGENATION RESEARCH NETWORK

CHESTDRAINOUTPUT24HOURS

0

200

400

600

800

1000

1200

Kategori1 Kategori2

Serie1

Serie1

Page 11: Patients. Clinical Trial Haukeland University Hospital …rdcr.org/wp-content/uploads/2016/07/11-Strandenes-Cold-platelets.pdf · Patients. Clinical Trial Haukeland University Hospital

THOR - TRAUMA HEMOSTASIS & OXYGENATION RESEARCH NETWORK

AVERAGENUMBEROFPLATELETUNITSUSED

0

0.5

1

1.5

2

2.5

3

Kategori1 Kategori2

Serie1

Serie1

Page 12: Patients. Clinical Trial Haukeland University Hospital …rdcr.org/wp-content/uploads/2016/07/11-Strandenes-Cold-platelets.pdf · Patients. Clinical Trial Haukeland University Hospital

THOR - TRAUMA HEMOSTASIS & OXYGENATION RESEARCH NETWORK

ADVERSEEFFECTSDUETOTRANSFUSIONOFCOLDPLT`S??

•  NOTROMBOEMBOLICEVENTSFIRST24HOURS

Page 13: Patients. Clinical Trial Haukeland University Hospital …rdcr.org/wp-content/uploads/2016/07/11-Strandenes-Cold-platelets.pdf · Patients. Clinical Trial Haukeland University Hospital

THOR - TRAUMA HEMOSTASIS & OXYGENATION RESEARCH NETWORK

THEWAYFORWARD

•  ENDTHISSTUDYWHEN20INEACHARM•  PROCEEDWITHUPTO14DAYSOFCOLDSTORAGENONAGITATED

•  COMPARE1:1:1USINGCOLDSTOREDAPHERESISPLT`SANDCOLDSTOREDWHOLEBLOOD

•  STARTUSINGCOLDSTOREDWHOLEBLOODINTHETRAUMAPACKSSTARTINGSEPTEMBER??