Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000581
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
1999-10-27
Brief Title:
Granulocyte Transfusion Study
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01-HB-6-2973 | OTHER_GRANT | US NIH Contract Number | None |
| N01-HB-6-2970 | OTHER_GRANT | None | None |
| N01-HB-6-2971 | OTHER_GRANT | None | None |
| N01-HB-6-2972 | OTHER_GRANT | None | None |