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Trial NCT00000581

Resource URI: http://static.linkedct.org/resource/trials/NCT00000581
linkedct:brief_title Granulocyte Transfusion Study
linkedct:condition <http://static.linkedct.org/resource/condition/1725>
linkedct:condition <http://static.linkedct.org/resource/condition/6582>
linkedct: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
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 12 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000581
rdfs:label Trial NCT00000581
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000581
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 301
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/19431>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/50569>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/51905>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000581>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/43172>
linkedct:reference <http://static.linkedct.org/resource/reference/43906>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date September 1976
linkedct:study_design Prevention, Randomized
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date January 2000