|- candidate number||1494|
|- NTR Number||NTR296|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||9-sep-2005|
|- Secondary IDs||P03.113 |
|- Public Title||Efficacy of Transfusions with platelets stored in platelet additive solution II versus plasma.|
|- Scientific Title||A multicenter randomised study of the efficacy of transfusions with platelets stored in platelet additive solution II versus plasma.|
|- ACRONYM||platelet transfusions and efficacy|
|- hypothesis||Utilization 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) studied||Cancer, Hemato-oncological patients, Thrombocytopenia|
|- Inclusion criteria||Patients > 18 years expected to receive platelet transfusions.|
|- Exclusion criteria||HLA- and/or HPA allo-immunization.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2003|
|- planned closingdate||30-apr-2005|
|- Target number of participants||195|
|- Interventions||Platelet transfusion, trigger based.|
|- Primary outcome||1- and 24-hour corrected count increment.|
|- Secondary outcome||1. Bleeding complications;|
2. Transfusion reactions;
3. Transfusion interval.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||M.D. J.L.H. Kerkhoffs|
|- CONTACT for SCIENTIFIC QUERIES||M.D. J.L.H. Kerkhoffs|
|- Sponsor/Initiator ||Leyenburg Hospital, Department of Hematology|
(Source(s) of Monetary or Material Support)
|- Publications||Blood. 2006 Nov 1;108(9):3210-5. Epub 2006 Jul 6.|
|- Brief summary||Introduction:|
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.
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)|
|- RECORD||9-sep-2005 - 9-jul-2008|