Heparin-Induced Thrombocytopenia: Development and Validation of a Predictive Clinical

NCT00748839 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2700

Last updated 2012-11-27

No results posted yet for this study

Summary

Although Heparin-induced thrombocytopenia (HIT) is a rare complication of heparin treatment, it results in a high rate of morbidity and mortality, the cumulative rate of thrombosis recurrence, amputation and death approaching 52 % at one month if no specific treatment is initiated. It is therefore vital to diagnose HIT as early and as reliably as possible to permit appropriate management of this rare condition.

During the acute phase of HIT, clinicians and biologists can only suspect this complication with a greater or lesser degree of confidence. Clinical data are not sufficiently sensitive or specific to confirm or refute thr diagnosis of HIT.

Conditions

  • Heparin-induced Thrombocytopenia

Sponsors & Collaborators

  • Hyphen BioMed

    collaborator UNKNOWN
  • CIC-EC de Saint-Etienne

    collaborator UNKNOWN
  • Groupe d'étude sur l'Hémostase et la Thrombose

    collaborator UNKNOWN
  • Association Française des centres régionaux de Pharmacovigilance

    collaborator UNKNOWN
  • Laboratoires Organon

    collaborator UNKNOWN
  • Sanofi

    collaborator INDUSTRY
  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Bernard TARDY, MD · CHU de Saint-Etienne

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00748839 on ClinicalTrials.gov