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Evaluation of the Efficacy of Platelets Treated With Pathogen Reduction Process

NCT01789762 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 842

Last updated 2019-04-29

No results posted yet for this study

Summary

This study is a multicentre, double-blind, randomized therapeutic trial.

The primary objective of this study is to evaluate non-inferiority with regard to prevention and control of haemorrhage:

* of platelet concentrates treated by pathogen reduction(Intercept amotosalen and UVA procedure)
* compared with the usual platelet concentrates (in additive solution intersol), reference arm, and
* compared with platelet concentrates re-suspended in autologous plasma (historic arm) These three products are available and authorised by ANSM (formerly AFSSAPS).

The secondary objectives is to evaluate the transfusion needs, transfusion outcomes and safety and the decreased frequency of grade 2 or higher side effects related to transfusion allergy to platelets.

Conditions

  • Aplasia With Expected Thrombocytopenia

Interventions

BIOLOGICAL

Autologous plasma

Transfusions of platelet concentrates re-suspended in autologous plasma

BIOLOGICAL

Additive solution

Transfusions of platelets prepared in additive solution (Intersol)

BIOLOGICAL

Pathogen reduction process

Patients transfused with platelets treated by pathogen reduction process

Sponsors & Collaborators

  • University Hospital, Grenoble

    collaborator OTHER

  • Etablissement Français du Sang

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01789762 on ClinicalTrials.gov