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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2005-05-31

Brief Summary

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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

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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.

Conditions

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Hemato-Oncologic Patients Myelosuppression Thrombocytopenia

Keywords

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Thrombopenia Platelet transfusion Increment Transfusion reactions Bleeding complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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platelet transfusion

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

\-

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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J.L.H. Kerkhoffs, MD

Role: PRINCIPAL_INVESTIGATOR

Sanquin rbbd

Locations

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Leiden University Medical centre

Leiden, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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P03.113

Identifier Type: -

Identifier Source: org_study_id