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Granulocyte Transfusion Study

NCT ID: NCT00000581

Last Updated: 2013-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1976-09-30

Study Completion Date

1981-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Blood Transfusion Infection

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

PREVENTION

Interventions

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leukocyte transfusions

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role lead

Principal Investigators

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Robert Gale

Role:

University of California

Geoffrey Herzig

Role:

Washington University School of Medicine

Ronald Strauss

Role:

University of Iowa

References

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Strauss RG, Connett JE, Gale RP, Bloomfield CD, Herzig GP, McCullough J, Maguire LC, Winston DJ, Ho W, Stump DC, Miller WV, Koepke JA. A controlled trial of prophylactic granulocyte transfusions during initial induction chemotherapy for acute myelogenous leukemia. N Engl J Med. 1981 Sep 10;305(11):597-603. doi: 10.1056/NEJM198109103051101.

Reference Type BACKGROUND
PMID: 6790985 (View on PubMed)

Winston DJ, Ho WG, Gale RP. Prophylactic granulocyte transfusions during chemotherapy of acute nonlymphocytic leukemia. Ann Intern Med. 1981 May;94(5):616-22. doi: 10.7326/0003-4819-94-5-616.

Reference Type BACKGROUND
PMID: 6263139 (View on PubMed)

Other Identifiers

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N01-HB-6-2970

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

N01-HB-6-2971

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

N01-HB-6-2972

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

N01-HB-6-2973

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

301

Identifier Type: -

Identifier Source: org_study_id