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Granulocyte Transfusion Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000581
First Posted: October 28, 1999
Last Update Posted: November 26, 2013
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:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
To evaluate granulocyte transfusion therapy with respect to its prophylactic and therapeutic effectiveness to prevent and aid recovery from infection. The study trials were conducted simultaneously.

Condition Intervention Phase
Blood Transfusion Infection Procedure: leukocyte transfusions Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1976
Study Completion Date: September 1981
Detailed Description:

BACKGROUND:

Infection remains a major cause of death in patients receiving chemotherapy for malignant diseases. One approach to the problem of septicemia and high mortality in these patients was the therapeutic use of granulocyte transfusions. Improvements in collection techniques, employing continuous flow centrifugation, permitted the collection of granulocytes from a single, normal donor in sufficient numbers to study their application in the treatment of infections in granulocytopenic patients. Studies had demonstrated the efficacy of granulocyte transfusions as an adjunct in the therapy of septicemia due to gram negative microorganisms associated with granulocytopenia.

The aims of the study were to determine (1) whether infections could be prevented in patients who received granulocytes prophylactically and (2) whether recovery from infection was aided in patients who received granulocytes therapeutically. Both trials utilized controls who received no granulocytes.

Four contracts were awarded in September 1976. The protocol designed to evaluate the efficacy of prophylactic granulocyte transfusions was completed at the close of 1977. The protocol for the therapeutic trial was completed in April 1978. Approximately 90 patients were randomized in the prophylactic trial and 51 in the therapeutic trial. The Recruitment and Intervention Phase ended in February 1980. The trial has concluded.

DESIGN NARRATIVE:

Prophylactic Trial and Therapeutic Trial: randomized, non-blind, sequential. Eligible patients were randomized to daily granulocyte transfusions or no granulocyte transfusions.

The study completion date listed in this record was inferred from the first publication listed in the Citations section of this study record.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Prophylactic Trial: males and females, 12 years or older, who were in the first induction phase of chemotherapy for acute leukemia, who had severe neutropenia, and who did not have documented infection.

Therapeutic Trial: males and females, any

  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): NCT00000581


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Robert Gale University of California
OverallOfficial: Geoffrey Herzig Washington University School of Medicine
OverallOfficial: Ronald Strauss University of Iowa
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000581     History of Changes
Other Study ID Numbers: 301
N01-HB-6-2970 ( Other Grant/Funding Number: US NIH Contract Number )
N01-HB-6-2971 ( Other Grant/Funding Number: US NIH Contract Number )
N01-HB-6-2972 ( Other Grant/Funding Number: US NIH Contract Number )
N01-HB-6-2973 ( Other Grant/Funding Number: US NIH Contract Number )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: November 26, 2013
Last Verified: January 2000