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

Primary Purpose

Hemato-Oncologic Patients, Myelosuppression, Thrombocytopenia

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
platelet transfusion
Sponsored by
Sanquin Research & Blood Bank Divisions
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemato-Oncologic Patients focused on measuring Thrombopenia, Platelet transfusion, Increment, Transfusion reactions, Bleeding complication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:patients > 18 years expected to receive platelet transfusions and informed consent - Exclusion Criteria:HLA- and/or HPA- alloimmunization -

Sites / Locations

  • Leiden University Medical centre

Outcomes

Primary Outcome Measures

Corrected count increment

Secondary Outcome Measures

Bleeding complications

Full Information

First Posted
September 7, 2005
Last Updated
February 26, 2007
Sponsor
Sanquin Research & Blood Bank Divisions
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1. Study Identification

Unique Protocol Identification Number
NCT00151866
Brief Title
Efficacy of Transfusions With Platelets Stored in Platelet Additive Solution II Versus Plasma
Official Title
A Multicentre Randomised Study of the Efficacy of Transfusions With Platelets Stored in Platelet Additive Solution II Versus Plasma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sanquin Research & Blood Bank Divisions

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemato-Oncologic Patients, Myelosuppression, Thrombocytopenia
Keywords
Thrombopenia, Platelet transfusion, Increment, Transfusion reactions, Bleeding complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
180 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
platelet transfusion
Primary Outcome Measure Information:
Title
Corrected count increment
Secondary Outcome Measure Information:
Title
Bleeding complications

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:patients > 18 years expected to receive platelet transfusions and informed consent - Exclusion Criteria:HLA- and/or HPA- alloimmunization -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J.L.H. Kerkhoffs, MD
Organizational Affiliation
Sanquin rbbd
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leiden University Medical centre
City
Leiden
Country
Netherlands

12. IPD Sharing Statement

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

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