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

Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151866
• Other study ID #: P03.113
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: February 26, 2007
• Start date: October 2003
• Est. completion date: May 2005

Study information

• Verified date: September 2005
• Source: Sanquin Research & Blood Bank Divisions
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:HLA- and/or HPA- alloimmunization

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemato-Oncologic Patients
• Myelosuppression
• Thrombocytopenia
• Thrombocytosis

Intervention

Procedure:
• platelet transfusion

Locations

Country	Name	City	State
Netherlands	Leiden University Medical centre	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Sanquin Research & Blood Bank Divisions

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corrected count increment
Secondary	Bleeding complications