Etiology of Blood Dyscrasias: Analysis of the International Agranulocytosis and Aplastic Anemia Study Data

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005307
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: May 2000
  Purpose

To quantify the role of drugs and other factors in the etiology of agranulocytosis and aplastic anemia.


Condition
Anemia, Aplastic
Blood Disease
Agranulocytosis

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: April 1989
Estimated Study Completion Date: March 1991
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00005307     History of Changes
Other Study ID Numbers: 3009
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Agranulocytosis
Anemia
Anemia, Aplastic
Hematologic Diseases
Bone Marrow Diseases
Leukocyte Disorders
Leukopenia

ClinicalTrials.gov processed this record on October 21, 2014