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

This study has been completed.
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00748839
First received: September 5, 2008
Last updated: November 22, 2012
Last verified: November 2012
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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)

Resource links provided by NLM:


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

blood sample


Enrollment: 2700
Study Start Date: March 2009
Study Completion Date: November 2012
Primary Completion Date: November 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00748839     History of Changes
Other Study ID Numbers: 0801016
Study First Received: September 5, 2008
Last Updated: November 22, 2012
Health Authority: France: Ministry of Health
France: French Data Protection Authority

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

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 16, 2014