Efficacy of Transfusions With Platelets Stored in Platelet Additive Solution II Versus Plasma
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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 |
- Corrected count increment
- Bleeding complications
| Estimated Enrollment: | 180 |
| Study Start Date: | October 2003 |
| Estimated Study Completion Date: | May 2005 |
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 |
Inclusion Criteria:patients > 18 years expected to receive platelet transfusions and informed consent -
Exclusion Criteria:HLA- and/or HPA- alloimmunization
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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 May 21, 2013