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OpenTrials
Completed

NCT Number: NCT00748839

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

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.

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Key information

Conditions

Heparin-Induced Thrombocytopenia Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ETS de Franche Conté - Laboratoire d'Immuno Hématologie, Besançon, France

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About this study

Purpose : To create and validate a score predicting the diagnosis of HIT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all patients presenting, either during or immediately after treatment:
  • thrombocytopenia and/or venous or arterial thrombosis
  • for whom a request for biological assessment to check for HIT (anti-H-PF4 ELISA test) is to be addressed to the specialized haemostasis laboratory participating in the study

Exclusion criteria

  • do not possess sufficient clinical data prior to performance of the biological test
  • cannot assure follow-up of the patient until normalization of the platelet count

Treatment and study plan

Primary outcomes

  1. the final diagnosis of HIT established by five independent experts in haemostasis and determined by thrombocytopenia and confirmation of HIT by immunological and/or functional tests

    Time frame: inclusion and 40 days after the inclusion

Secondary outcomes

  1. pathogenic nature of anti HPF4 antibodies of IgM and IgA type

    Time frame: inclusion

  2. new biological test detecting HIT

    Time frame: inclusion

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Association Française des centres régionaux de Pharmacovigilance
  • CIC-EC de Saint-Etienne
  • Groupe d'étude sur l'Hémostase et la Thrombose
  • Hyphen BioMed
  • Laboratoires Organon
  • Sanofi

Registry information

Official study title

Heparin-Induced Thrombocytopenia : Development and Validation of a Predictive Clinical Score: a Prospective Multicenter Study Under the Auspices of the French Haemostasis and Thrombosis Study Group (GEHT)in Cooperation With the French Association of Regional PharmacoVigilance Center (AFCRPV)

Acronym: Score-TIH

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Sep 9, 2008
Registry last updated
Nov 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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