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Efficacy of Transfusions with platelets stored in platelet additive solution II versus plasma.


- candidate number1494
- NTR NumberNTR296
- ISRCTNISRCTN52543592
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR9-sep-2005
- Secondary IDsP03.113 
- Public TitleEfficacy of Transfusions with platelets stored in platelet additive solution II versus plasma.
- Scientific TitleA multicenter randomised study of the efficacy of transfusions with platelets stored in platelet additive solution II versus plasma.
- ACRONYMplatelet transfusions and efficacy
- hypothesisUtilization of platelets stored in additive solutions has several advantages. A former RCT testing platelets stored in platelet additive solution II versus plasma excluded patients with factors of increased platelet consumption.
In this study also this category of patients are included and we expect to find differences in outcome, as compared to the previous study.
- Healt Condition(s) or Problem(s) studiedCancer, Hemato-oncological patients, Thrombocytopenia
- Inclusion criteriaPatients > 18 years expected to receive platelet transfusions.
- Exclusion criteriaHLA- and/or HPA allo-immunization.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2003
- planned closingdate30-apr-2005
- Target number of participants195
- InterventionsPlatelet transfusion, trigger based.
- Primary outcome1- and 24-hour corrected count increment.
- Secondary outcome1. Bleeding complications;
2. Transfusion reactions;
3. Transfusion interval.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESM.D. J.L.H. Kerkhoffs
- CONTACT for SCIENTIFIC QUERIESM.D. J.L.H. Kerkhoffs
- Sponsor/Initiator Leyenburg Hospital, Department of Hematology
- Funding
(Source(s) of Monetary or Material Support)
[default]
- PublicationsBlood. 2006 Nov 1;108(9):3210-5. Epub 2006 Jul 6.
- Brief summaryIntroduction:
Utilization of platelet additive solutions (PASs) for storage of platelets has several advantages, however randomised studies testing the clinical efficacy are scarce.
A prospective, randomised study comparing the efficacy of transfusions with platelets stored in Platelet Additive Solution II (PAS II) versus plasma showed that CCIs after transfusion with platelets stored in PAS II were significantly lower (1). Major drawbacks of this study were the exclusion of patients with clinical factors known to increase platelet consumption and a limited number of patients.
A multicenter, randomised study to investigate clinical efficacy of platelets stored in PAS II versus plasma, also including patients with factors of increased platelet consumption, was performed.


Methods:
After consent patients > 18 years, without HLA- and/or HPA-alloantibodies, were randomised to receive pooled platelet concentrates (PC) suspended in either plasma or PAS II, leucoreduced, and stored up to 5 days. 1- and 24-hour CCI were the primary endpoints.
Secondary endpoints were transfusion interval, adverse reactions and bleeding complications.
An inclusion-period was defined as a maximum of 8 transfusions or 30 days after the first transfusion.
- Main changes (audit trail)
- RECORD9-sep-2005 - 9-jul-2008


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