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

A Multicentre Randomised Study of the Efficacy of Transfusions With Platelets Stored in Platelet Additive Solution II Versus Plasma

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00151866
Enrollment
180
Registered
2005-09-09
Start date
2003-10-31
Completion date
2005-05-31
Last updated
2007-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemato-Oncologic Patients, Myelosuppression, Thrombocytopenia

Keywords

Thrombopenia, Platelet transfusion, Increment, Transfusion reactions, Bleeding complication

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.

Interventions

PROCEDUREplatelet transfusion

Sponsors

Sanquin Research & Blood Bank Divisions
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

patients \> 18 years expected to receive platelet transfusions and informed consent -

Exclusion criteria

HLA- and/or HPA- alloimmunization \-

Design outcomes

Primary

MeasureTime frame
Corrected count increment

Secondary

MeasureTime frame
Bleeding complications

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026