Randomized Trial Of Platelet Transfusion Policies After Blood Stem Cells Transplantation In Young Children: Reduction Of Number Of Single Platelet Concentrate Donors Per Child

December 13, 2005 updated by: Gustave Roussy, Cancer Campus, Grand Paris
Randomized Trial Of Platelet Transfusion Policies After Blood Stem Cells Transplantation In Young Children: Reduction Of Number Of Single Platelet Concentrate Donors Per Child

Study Overview

Study Type

Interventional

Enrollment

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Villejuif, France, 94800
        • Institut Gustave-Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children weighing 30 kg or less with a diagnosis of haematological malignancy or solid tumour, who were candidates for HSCT were eligible for inclusion in the study.
  • Written informed consent was required from parents of eligible children.

Exclusion Criteria:

  • Children were excluded if they had a anti-HLA and/or anti-HPA antibody, if they were prior included in this study or if the parents declined to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary end point of the study was tocompare the number of platelet concentrates donors who were implicated in platelet transfusion supportive after HSCT.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Valérie LAPIERRE, MD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1995

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

December 14, 2005

Last Update Submitted That Met QC Criteria

December 13, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Other Study ID Numbers

  • Minnie
  • CSET 94/357

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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