Efficacy of Transfusions With Platelets Stored in Platelet Additive Solution II Versus Plasma

Phase 3

Completed

• Conditions: Hemato-Oncologic Patients; Myelosuppression; Thrombocytopenia

• Registration Number: NCT00151866
• Lead Sponsor: Sanquin Research & Blood Bank Divisions

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.

Study Timeline

• Study Start: 2003-10
• Study Completion: 2005-05
• Status Verified: 2005-09
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-09
• Last Update Submitted: 2007-02-26
• Last Update Posted: 2007-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

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

Exclusion Criteria

HLA- and/or HPA- alloimmunization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Corrected count increment

Secondary Outcome Measures

Name	Time	Method
Bleeding complications

Trial Locations

Locations (1)

Leiden University Medical centre; 🇳🇱 Leiden, Netherlands