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

Sponsor
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00005307
Collaborator
(none)
23
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Study Start Date :
    Apr 1, 1989
    Actual Study Completion Date :
    Mar 1, 1991

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A to 100 Years
      Sexes Eligible for Study:
      Male
      Accepts Healthy Volunteers:
      No

      No eligibility criteria

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • National Heart, Lung, and Blood Institute (NHLBI)

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00005307
      Other Study ID Numbers:
      • 3009
      • R01HL042524
      First Posted:
      May 26, 2000
      Last Update Posted:
      May 13, 2016
      Last Verified:
      May 1, 2000
      Additional relevant MeSH terms:
      Anemia
      Hematologic Diseases
      Anemia, Aplastic
      Agranulocytosis

      Study Results

      No Results Posted as of May 13, 2016