Etiology of Blood Dyscrasias: Analysis of the International Agranulocytosis and Aplastic Anemia Study Data
Primary Purpose
Anemia, Aplastic, Blood Disease, Agranulocytosis
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Anemia, Aplastic
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005307
First Posted
May 25, 2000
Last Updated
May 12, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005307
Brief Title
Etiology of Blood Dyscrasias: Analysis of the International Agranulocytosis and Aplastic Anemia Study Data
Study Type
Observational
2. Study Status
Record Verification Date
May 2000
Overall Recruitment Status
Completed
Study Start Date
April 1989 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 1991 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Aplastic, Blood Disease, Agranulocytosis
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Citations:
PubMed Identifier
1672513
Citation
Kelly JP, Kaufman DW, Shapiro S. Risks of agranulocytosis and aplastic anemia in relation to the use of cardiovascular drugs: The International Agranulocytosis and Aplastic Anemia Study. Clin Pharmacol Ther. 1991 Mar;49(3):330-41. doi: 10.1038/clpt.1991.37.
Results Reference
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Etiology of Blood Dyscrasias: Analysis of the International Agranulocytosis and Aplastic Anemia Study Data
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