Overview

This trial is active, not recruiting.

Condition children treated with high-dose chemotherapy (hdc) followed by haematopoietic stem cell transplantation (hsct)
Treatment platelet concentrates
Phase phase 3
Sponsor Gustave Roussy, Cancer Campus, Grand Paris
Start date October 1995
Trial size 120 participants
Trial identifier NCT00180986, CSET 94/357, Minnie

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

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.
time frame:

Eligibility Criteria

Male or female participants up to 15 years old.

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.

Additional Information

Official title Randomized Trial Of Platelet Transfusion Policies After Blood Stem Cells Transplantation In Young Children: Reduction Of Number Of Single Platelet Concentrate Donors Per Child
Principal investigator Valérie LAPIERRE, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2005.
Information provided to ClinicalTrials.gov by Gustave Roussy, Cancer Campus, Grand Paris.