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

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

This study is not yet open for participant recruitment.

Verified by Centre Hospitalier Universitaire de Saint Etienne, September 2008

Sponsors and Collaborators:	Centre Hospitalier Universitaire de Saint Etienne 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 Sanofi-Aventis
Information provided by:	Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:	NCT00748839

Purpose

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.

Condition
Heparin-Induced Thrombocytopenia

MedlinePlus related topics: Blood Thinners

Drug Information available for: Immunoglobulins Globulin, Immune Heparin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official 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)

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

pathogenic nature of anti HPF4 antibodies of IgM and IgA type [ Time Frame: inclusion ] [ Designated as safety issue: No ]
new biological test detecting HIT [ Time Frame: inclusion ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

blood sample

Estimated Enrollment:	3000
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

community sample

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748839

Contacts

Contact: Bernard TARDY, MD

+33477127788

bernardtardy@yahoo.fr

Locations

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

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

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

Sanofi-Aventis

Investigators

Principal Investigator:

Bernard TARDY, MD

CHU de Saint-Etienne

More Information

Responsible Party:	CHU de Saint-Etienne ( Professeur Bernard Tardy )
Study ID Numbers:	0801016
Study First Received:	September 5, 2008
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00748839
Health Authority:	France: Ministry of Health

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:

HIT
Heparin-induced thrombocytopenia
heparin treatment
venous thrombosis

arterial thrombosis
predictive clinical score
biological test
anti-H-PF4 antibodies

Study placed in the following topic categories:

Thrombocytopathy
Antibodies
Thrombocytopenia
Platelet Factor 4
Heparin-induced thrombocytopenia
Hematologic Diseases

Blood Platelet Disorders
Venous Thrombosis
Heparin
Thrombosis
Immunoglobulins
Calcium heparin

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009