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

NCT ID: NCT00748839

Last Updated: 2012-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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

Conditions

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Heparin-induced Thrombocytopenia

Keywords

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HIT Heparin-induced thrombocytopenia heparin treatment venous thrombosis arterial thrombosis predictive clinical score biological test anti-H-PF4 antibodies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hyphen BioMed

UNKNOWN

Sponsor Role collaborator

CIC-EC de Saint-Etienne

UNKNOWN

Sponsor Role collaborator

Groupe d'étude sur l'Hémostase et la Thrombose

UNKNOWN

Sponsor Role collaborator

Association Française des centres régionaux de Pharmacovigilance

UNKNOWN

Sponsor Role collaborator

Laboratoires Organon

UNKNOWN

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bernard TARDY, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

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ETS de Franche Conté - Laboratoire d'Immuno Hématologie

Besançon, , France

Site Status

CHU Cavale Blanche Laboratoire d'Hématologie

Brest, , France

Site Status

Laboratoire d'hématologie - Hôpital Louis Pradel

Bron, , France

Site Status

Hôpital Antoine Beclère - Laboratoire d'hématologie

Clamart, , France

Site Status

Laboratoire d'hématologie - CHU de Clermont Ferrand

Clermont-Ferrand, , France

Site Status

HCC Colmar - laboratoire d'hématologie

Colmar, , France

Site Status

Laboratoire d'Hématologie - CHU le Bocage

Dijon, , France

Site Status

Laboratoire d'hémostase - CCML

Le Plessis-Robinson, , France

Site Status

Hôpital Cardiologique - Laboratoire d'Hémostase

Lille, , France

Site Status

CHU La Timone - Laboratoire Hématologie

Marseille, , France

Site Status

Hôpital SAINT ELOI - CHU de Montpellier - Laboratoire d'Hématologie

Montpellier, , France

Site Status

Hématologie biologique - CHU Nancy

Nancy, , France

Site Status

HOTEL DIEU - CHU Nantes - Laboratoire d'Hématologie

Nantes, , France

Site Status

Hématologie Biologique - Hôpital Tenon,

Paris, , France

Site Status

Hôpital Necker Enfants Malades -Laboratoire d'Hématologie

Paris, , France

Site Status

Hôpital BICHAT - Service d'hématologie immunologie

Paris, , France

Site Status

G.H. Pitié Salpétrière - Labo Hémostase Pavillon Laveran

Paris, , France

Site Status

Hôpital Européen Georges Pompidou - Service Hématologie Biologique A

Paris, , France

Site Status

Hôpital Cardiologique - CHU Bordeaux

Pessac, , France

Site Status

Laboratoire central d'hématologie - Hôpital R. DEBRE

Reims, , France

Site Status

CHU de ROUEN

Rouen, , France

Site Status

Laboratoire d'hématologie

Saint-Etienne, , France

Site Status

Service d'Urgence et de Réanimation

Saint-Etienne, , France

Site Status

CHU Strasbourg Hautepierre Laboratoire d'Hématologie

Strasbourg, , France

Site Status

CMC Foch Laboratoire d'hémostase

Suresnes, , France

Site Status

Hopital Purpan - Laboratoire d'hématologie

Toulouse, , France

Site Status

CHU Trousseau - CTH - Service d'Hématologie Hémostase

Tours, , France

Site Status

Countries

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France

References

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Tardy-Poncet B, de Maistre E, Pouplard C, Presles E, Alhenc-Gelas M, Lasne D, Horellou MH, Mouton C, Serre-Sapin A, Bauters A, Nguyen P, Mullier F, Perrin J, Le Gal G, Morange PE, Grunebaum L, Lillo-Le Louet A, Elalamy I, Gruel Y, Greinacher A, Lecompte T, Tardy B; GFHT-HIT study group. Heparin-induced thrombocytopenia: Construction of a pretest diagnostic score derived from the analysis of a prospective multinational database, with internal validation. J Thromb Haemost. 2021 Aug;19(8):1959-1972. doi: 10.1111/jth.15344. Epub 2021 Jun 14.

Reference Type DERIVED
PMID: 33872452 (View on PubMed)

Other Identifiers

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0801016

Identifier Type: -

Identifier Source: org_study_id