Ignite Creation Date:
2024-05-05 @ 1:26 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005307
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-05-25
Brief Title:
Etiology of Blood Dyscrasias Analysis of the International Agranulocytosis and Aplastic Anemia Study Data
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:
2000-05
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 quantify the role of drugs and other factors in the etiology of agranulocytosis and aplastic anemia
Detailed Description:
BACKGROUND
Agranulocytosis and aplastic anemia are rare but serious blood diseases that can be caused by drugs and other environmental factors In 1980 there were only limited quantitative estimates of the risk between various exposures particularly drugs and the two dyscrasias The data were collected in the IAAAS a multicenter population-based case-control study conducted from 1980 to 1986 in eight regions The study was funded by a pharmaceutical company to investigate a single hypothesis but information was obtained on all drugs and on other factors enabling a general investigation of the dyscrasias
DESIGN NARRATIVE
The study was for retrospective data analysis only Standard case-control methods were used In most instances multivariate analysis was used to control confounding especially by simultaneous use of other causal drugs Adverse effects and the relative safety of drugs in relation to the two dyscrasias were documented Because the IAAAS was population-based incidence rates were provided directly and excess risks were estimated for associated drugs Such quantitative measures of association were generally unavailable Among the drugs that were analyzed were various categories such as psychotropics antihistamines and cardiovascular drugs and individual drugs such as allopurinol Factors other than drugs were also evaluated including exposure to radiation and chemicals such as benzene and insecticides history of viral infection and history of allergy and other conditions
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Agranulocytosis and aplastic anemia are rare but serious blood diseases that can be caused by drugs and other environmental factors In 1980 there were only limited quantitative estimates of the risk between various exposures particularly drugs and the two dyscrasias The data were collected in the IAAAS a multicenter population-based case-control study conducted from 1980 to 1986 in eight regions The study was funded by a pharmaceutical company to investigate a single hypothesis but information was obtained on all drugs and on other factors enabling a general investigation of the dyscrasias
DESIGN NARRATIVE
The study was for retrospective data analysis only Standard case-control methods were used In most instances multivariate analysis was used to control confounding especially by simultaneous use of other causal drugs Adverse effects and the relative safety of drugs in relation to the two dyscrasias were documented Because the IAAAS was population-based incidence rates were provided directly and excess risks were estimated for associated drugs Such quantitative measures of association were generally unavailable Among the drugs that were analyzed were various categories such as psychotropics antihistamines and cardiovascular drugs and individual drugs such as allopurinol Factors other than drugs were also evaluated including exposure to radiation and chemicals such as benzene and insecticides history of viral infection and history of allergy and other conditions
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS 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 |
|---|---|---|---|
| R01HL042524 | NIH | None | httpsreporternihgovquickSearchR01HL042524 |