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Granulocyte Transfusion Study

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ClinicalTrials.gov Identifier: NCT00000581
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : November 26, 2013
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
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 or disease Intervention/treatment Phase
Blood Transfusion Infection Procedure: leukocyte transfusions Phase 3

Detailed Description:


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.


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.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Prevention
Study Start Date : September 1976
Study Completion Date : September 1981

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U.S. FDA Resources

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

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

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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)
OverallOfficial: Robert Gale University of California
OverallOfficial: Geoffrey Herzig Washington University School of Medicine
OverallOfficial: Ronald Strauss University of Iowa

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 Posted: October 28, 1999    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: January 2000