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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00180986
First Posted: September 16, 2005
Last Update Posted: December 14, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00180986


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

ClinicalTrials.gov Identifier: NCT00180986     History of Changes
Other Study ID Numbers: Minnie
CSET 94/357
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: December 14, 2005
Last Verified: September 2005