Heparin-Induced Thrombocytopenia: Development and Validation of a Predictive Clinical (Score-TIH)

November 22, 2012 updated by: Centre Hospitalier Universitaire de Saint Etienne

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)

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

2700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25020
        • ETS de Franche Conté - Laboratoire d'Immuno Hématologie
      • Brest, France, 29609
        • CHU Cavale Blanche Laboratoire d'Hématologie
      • Bron, France, 69500
        • Laboratoire d'hématologie - Hôpital Louis Pradel
      • Clamart, France, 92141
        • Hôpital Antoine Beclère - Laboratoire d'hématologie
      • Clermont Ferrand, France, 63003
        • Laboratoire d'hématologie - CHU de Clermont Ferrand
      • Colmar, France, 68024
        • HCC Colmar - laboratoire d'hématologie
      • Dijon, France, 21034
        • Laboratoire d'Hématologie - CHU le Bocage
      • Le Plessis Robinson, France, 92350
        • Laboratoire d'hémostase - CCML
      • Lille, France, 59037
        • Hôpital Cardiologique - Laboratoire d'Hémostase
      • Marseille, France, 13385
        • CHU La Timone - Laboratoire Hématologie
      • Montpellier, France, 34295
        • Hôpital SAINT ELOI - CHU de Montpellier - Laboratoire d'Hématologie
      • Nancy, France, 54511
        • Hématologie biologique - CHU Nancy
      • Nantes, France, 44093
        • HOTEL DIEU - CHU Nantes - Laboratoire d'Hématologie
      • Paris, France, 75002
        • Hématologie Biologique - Hôpital Tenon,
      • Paris, France, 75015
        • Hôpital Necker Enfants Malades -Laboratoire d'Hématologie
      • Paris, France, 75018
        • Hôpital BICHAT - Service d'hématologie immunologie
      • Paris, France, 75851
        • G.H. Pitié Salpétrière - Labo Hémostase Pavillon Laveran
      • Paris, France, 75908
        • Hôpital Européen Georges Pompidou - Service Hématologie Biologique A
      • Pessac, France, 33604
        • Hôpital Cardiologique - CHU Bordeaux
      • Reims, France, 51092
        • Laboratoire central d'hématologie - Hôpital R. DEBRE
      • Rouen, France, 76031
        • CHU de Rouen
      • Saint-Etienne, France, 42055
        • Laboratoire d'Hématologie
      • Saint-Etienne, France, 42055
        • Service d'Urgence et de Réanimation
      • Strasbourg, France, 67098
        • CHU Strasbourg Hautepierre Laboratoire d'Hématologie
      • Suresnes, France, 92151
        • CMC Foch Laboratoire d'hémostase
      • Toulouse, France, 31059
        • Hopital Purpan - Laboratoire d'hématologie
      • Tours, France, 37044
        • CHU Trousseau - CTH - Service d'Hématologie Hémostase

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

community sample

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
inclusion and 40 days after the inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
pathogenic nature of anti HPF4 antibodies of IgM and IgA type
Time Frame: inclusion
inclusion
new biological test detecting HIT
Time Frame: inclusion
inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

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

Investigators

  • Principal Investigator: Bernard TARDY, MD, CHU de Saint-Etienne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

September 5, 2008

First Submitted That Met QC Criteria

September 5, 2008

First Posted (Estimate)

September 9, 2008

Study Record Updates

Last Update Posted (Estimate)

November 27, 2012

Last Update Submitted That Met QC Criteria

November 22, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0801016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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