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Randomized Trial Of Platelet Transfusion Policies After Blood Stem Cells Transplantation In Young Children: Reduction Of Number Of Single Platelet Concentrate Donors Per Child
This study is ongoing, but not recruiting participants.
Sponsored by: Institut Gustave Roussy
Information provided by: Institut Gustave Roussy
ClinicalTrials.gov Identifier: NCT00180986
  Purpose

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


Condition Intervention Phase
Children Treated With High-Dose Chemotherapy (HDC) Followed by Haematopoietic Stem Cell Transplantation (HSCT)
Procedure: Platelet concentrates
Phase III

MedlinePlus related topics: Blood Transfusion and Donation
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Institut Gustave Roussy:

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

Estimated Enrollment: 120
Study Start Date: October 1995
  Eligibility

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00180986

Locations
France
Institut Gustave-Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Institut Gustave Roussy
Investigators
Principal Investigator: Valérie LAPIERRE, MD Institut Gustave Roussy
  More Information

Study ID Numbers: Minnie, CSET 94/357
Study First Received: September 13, 2005
Last Updated: December 13, 2005
ClinicalTrials.gov Identifier: NCT00180986  
Health Authority: France: Afssaps - French Health Products Safety Agency

ClinicalTrials.gov processed this record on January 16, 2009