Granulocyte Transfusion Study

November 25, 2013 updated by: National Heart, Lung, and Blood Institute (NHLBI)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Robert Gale, University of California
  • Geoffrey Herzig, Washington University School of Medicine
  • Ronald Strauss, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1976

Study Completion (Actual)

September 1, 1981

Study Registration Dates

First Submitted

October 27, 1999

First Submitted That Met QC Criteria

October 27, 1999

First Posted (Estimate)

October 28, 1999

Study Record Updates

Last Update Posted (Estimate)

November 26, 2013

Last Update Submitted That Met QC Criteria

November 25, 2013

Last Verified

January 1, 2000

More Information

Terms related to this study

Other Study ID Numbers

  • 301 (Yasar Calıskan)
  • 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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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