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Clinical Trials/NCT00151866
NCT00151866
Completed
Phase 3

A Multicentre Randomised Study of the Efficacy of Transfusions With Platelets Stored in Platelet Additive Solution II Versus Plasma

Sanquin Research & Blood Bank Divisions1 site in 1 country180 target enrollmentOctober 2003

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Hemato-Oncologic Patients
Sponsor
Sanquin Research & Blood Bank Divisions
Enrollment
180
Locations
1
Primary Endpoint
Corrected count increment
Status
Completed
Last Updated
19 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the clinical efficacy of transfusions with platelets stored in platelet additive solution II compared to plasma storage.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 2003
End Date
May 2005
Last Updated
19 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Sanquin Research & Blood Bank Divisions

Eligibility Criteria

Inclusion Criteria

  • patients \> 18 years expected to receive platelet transfusions and informed consent -

Exclusion Criteria

  • HLA- and/or HPA- alloimmunization

Outcomes

Primary Outcomes

Corrected count increment

Secondary Outcomes

  • Bleeding complications

Study Sites (1)

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