Clinical trial NCT00748839: Heparin-Induced Thrombocytopenia: Development and Validation of a Predictive Clinical
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heparin-induced Thrombocytopenia
Keywords: HIT
Heparin-induced thrombocytopenia
heparin treatment
venous thrombosis
arterial thrombosis
predictive clinical score
biological test
anti-H-PF4 antibodies
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Hyphen BioMed
name: CIC-EC de Saint-Etienne
name: Groupe d'étude sur l'Hémostase et la Thrombose
name: Association Française des centres régionaux de Pharmacovigilance
name: Laboratoires Organon
name: Sanofi
First posted: 2008-09-09
Enrollment: 2700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: community sample

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

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: inclusion and 40 days after the inclusion
Secondary outcomes:
measure: pathogenic nature of anti HPF4 antibodies of IgM and IgA type
timeFrame: inclusion
measure: new biological test detecting HIT
timeFrame: inclusion
Other outcomes:
Locations:
city: Besançon
country: France
facility: ETS de Franche Conté - Laboratoire d'Immuno Hématologie
city: Brest
country: France
facility: CHU Cavale Blanche Laboratoire d'Hématologie
city: Bron
country: France
facility: Laboratoire d'hématologie - Hôpital Louis Pradel
city: Clamart
country: France
facility: Hôpital Antoine Beclère - Laboratoire d'hématologie
city: Clermont Ferrand
country: France
facility: Laboratoire d'hématologie - CHU de Clermont Ferrand
city: Colmar
country: France
facility: HCC Colmar - laboratoire d'hématologie
city: Dijon
country: France
facility: Laboratoire d'Hématologie - CHU le Bocage
city: Le Plessis Robinson
country: France
facility: Laboratoire d'hémostase - CCML
city: Lille
country: France
facility: Hôpital Cardiologique - Laboratoire d'Hémostase
city: Marseille
country: France
facility: CHU La Timone - Laboratoire Hématologie
city: Montpellier
country: France
facility: Hôpital SAINT ELOI - CHU de Montpellier - Laboratoire d'Hématologie
city: Nancy
country: France
facility: Hématologie biologique - CHU Nancy
city: Nantes
country: France
facility: HOTEL DIEU - CHU Nantes - Laboratoire d'Hématologie
city: Paris
country: France
facility: Hématologie Biologique - Hôpital Tenon,
city: Paris
country: France
facility: Hôpital Necker Enfants Malades -Laboratoire d'Hématologie
city: Paris
country: France
facility: Hôpital BICHAT - Service d'hématologie immunologie
city: Paris
country: France
facility: G.H. Pitié Salpétrière - Labo Hémostase Pavillon Laveran
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou - Service Hématologie Biologique A
city: Pessac
country: France
facility: Hôpital Cardiologique - CHU Bordeaux
city: Reims
country: France
facility: Laboratoire central d'hématologie - Hôpital R. DEBRE
city: Rouen
country: France
facility: CHU de ROUEN
city: Saint-Etienne
country: France
facility: Laboratoire d'hématologie
city: Saint-Etienne
country: France
facility: Service d'Urgence et de Réanimation
city: Strasbourg
country: France
facility: CHU Strasbourg Hautepierre Laboratoire d'Hématologie
city: Suresnes
country: France
facility: CMC Foch Laboratoire d'hémostase
city: Toulouse
country: France
facility: Hopital Purpan - Laboratoire d'hématologie
city: Tours
country: France
facility: CHU Trousseau - CTH - Service d'Hématologie Hémostase
Study officials:
affiliation: CHU de Saint-Etienne
name: Bernard TARDY, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.