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

This study has been completed.
Sponsor:
Information provided by:
Sanquin Research & Blood Bank Divisions
ClinicalTrials.gov Identifier:
NCT00151866
First received: September 7, 2005
Last updated: February 26, 2007
Last verified: September 2005
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00151866     History of Changes
Other Study ID Numbers: P03.113
Study First Received: September 7, 2005
Last Updated: February 26, 2007
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Thrombocytopenia
Pancytopenia
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on July 26, 2014