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…
ID
Bron
Verkorte titel
Aandoening
1. Hemato-oncological patients;
2. Thrombocytopenia.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1- and 24-hour corrected count increment.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Platelet transfusion, trigger based.
Publiek
Leyweg 275
J.L.H. Kerkhoffs
Den Haag 2545 CH
The Netherlands
+31 (0)70 3592004
J.Kerkhoffs@hagaziekenhuis.nl
Wetenschappelijk
Leyweg 275
J.L.H. Kerkhoffs
Den Haag 2545 CH
The Netherlands
+31 (0)70 3592004
J.Kerkhoffs@hagaziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients > 18 years expected to receive platelet transfusions.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
HLA- and/or HPA allo-immunization.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL258 |
NTR-old | NTR296 |
Ander register | : P03.113 |
ISRCTN | ISRCTN52543592 |