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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00151866
First Posted: September 9, 2005
Last Update Posted: February 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanquin Research & Blood Bank Divisions
  Purpose
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.

Condition Intervention Phase
Hemato-Oncologic Patients Myelosuppression Thrombocytopenia Procedure: platelet transfusion Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multicentre Randomised Study of the Efficacy of Transfusions With Platelets Stored in Platelet Additive Solution II Versus Plasma

Resource links provided by NLM:


Further study details as provided by Sanquin Research & Blood Bank Divisions:

Primary Outcome Measures:
  • Corrected count increment

Secondary Outcome Measures:
  • Bleeding complications

Estimated Enrollment: 180
Study Start Date: October 2003
Estimated Study Completion Date: May 2005
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:HLA- and/or HPA- alloimmunization

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151866


Locations
Netherlands
Leiden University Medical centre
Leiden, Netherlands
Sponsors and Collaborators
Sanquin Research & Blood Bank Divisions
Investigators
Principal Investigator: J.L.H. Kerkhoffs, MD Sanquin rbbd
  More Information

ClinicalTrials.gov Identifier: NCT00151866     History of Changes
Other Study ID Numbers: P03.113
First Submitted: September 7, 2005
First Posted: September 9, 2005
Last Update Posted: February 27, 2007
Last Verified: September 2005

Keywords provided by Sanquin Research & Blood Bank Divisions:
Thrombopenia
Platelet transfusion
Increment
Transfusion reactions
Bleeding complication

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases