No registrations found.
ID
Source
Brief title
Health condition
1. Hemato-oncological patients;
2. Thrombocytopenia.
Sponsors and support
Intervention
Outcome measures
Primary outcome
1- and 24-hour corrected count increment.
Secondary outcome
1. Bleeding complications;
2. Transfusion reactions;
3. Transfusion interval.
Background 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.
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.
Study objective
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.
Study design
N/A
Intervention
Platelet transfusion, trigger based.
Leyweg 275
J.L.H. Kerkhoffs
Den Haag 2545 CH
The Netherlands
+31 (0)70 3592004
J.Kerkhoffs@hagaziekenhuis.nl
Leyweg 275
J.L.H. Kerkhoffs
Den Haag 2545 CH
The Netherlands
+31 (0)70 3592004
J.Kerkhoffs@hagaziekenhuis.nl
Inclusion criteria
Patients > 18 years expected to receive platelet transfusions.
Exclusion criteria
HLA- and/or HPA allo-immunization.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL258 |
NTR-old | NTR296 |
Other | : P03.113 |
ISRCTN | ISRCTN52543592 |