Heparin-Induced Thrombocytopenia: Development and Validation of a Predictive Clinical
Score-TIH
1 other identifier
observational
2,700
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2009
Typical duration for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2008
CompletedFirst Posted
Study publicly available on registry
September 9, 2008
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedNovember 27, 2012
November 1, 2012
3.7 years
September 5, 2008
November 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
inclusion and 40 days after the inclusion
Secondary Outcomes (2)
pathogenic nature of anti HPF4 antibodies of IgM and IgA type
inclusion
new biological test detecting HIT
inclusion
Eligibility Criteria
community sample
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier Universitaire de Saint Etiennelead
- Hyphen BioMedcollaborator
- CIC-EC de Saint-Etiennecollaborator
- Groupe d'étude sur l'Hémostase et la Thrombosecollaborator
- Association Française des centres régionaux de Pharmacovigilancecollaborator
- Laboratoires Organoncollaborator
- Sanoficollaborator
Study Sites (27)
ETS de Franche Conté - Laboratoire d'Immuno Hématologie
Besançon, 25020, France
CHU Cavale Blanche Laboratoire d'Hématologie
Brest, 29609, France
Laboratoire d'hématologie - Hôpital Louis Pradel
Bron, 69500, France
Hôpital Antoine Beclère - Laboratoire d'hématologie
Clamart, 92141, France
Laboratoire d'hématologie - CHU de Clermont Ferrand
Clermont-Ferrand, 63003, France
HCC Colmar - laboratoire d'hématologie
Colmar, 68024, France
Laboratoire d'Hématologie - CHU le Bocage
Dijon, 21034, France
Laboratoire d'hémostase - CCML
Le Plessis-Robinson, 92350, France
Hôpital Cardiologique - Laboratoire d'Hémostase
Lille, 59037, France
CHU La Timone - Laboratoire Hématologie
Marseille, 13385, France
Hôpital SAINT ELOI - CHU de Montpellier - Laboratoire d'Hématologie
Montpellier, 34295, France
Hématologie biologique - CHU Nancy
Nancy, 54511, France
HOTEL DIEU - CHU Nantes - Laboratoire d'Hématologie
Nantes, 44093, France
Hématologie Biologique - Hôpital Tenon,
Paris, 75002, France
Hôpital Necker Enfants Malades -Laboratoire d'Hématologie
Paris, 75015, France
Hôpital BICHAT - Service d'hématologie immunologie
Paris, 75018, France
G.H. Pitié Salpétrière - Labo Hémostase Pavillon Laveran
Paris, 75851, France
Hôpital Européen Georges Pompidou - Service Hématologie Biologique A
Paris, 75908, France
Hôpital Cardiologique - CHU Bordeaux
Pessac, 33604, France
Laboratoire central d'hématologie - Hôpital R. DEBRE
Reims, 51092, France
CHU de ROUEN
Rouen, 76031, France
Laboratoire d'hématologie
Saint-Etienne, 42055, France
Service d'Urgence et de Réanimation
Saint-Etienne, 42055, France
CHU Strasbourg Hautepierre Laboratoire d'Hématologie
Strasbourg, 67098, France
CMC Foch Laboratoire d'hémostase
Suresnes, 92151, France
Hopital Purpan - Laboratoire d'hématologie
Toulouse, 31059, France
CHU Trousseau - CTH - Service d'Hématologie Hémostase
Tours, 37044, France
Related Publications (1)
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.
PMID: 33872452DERIVED
Biospecimen
blood sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bernard TARDY, MD
CHU de Saint-Etienne
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2008
First Posted
September 9, 2008
Study Start
March 1, 2009
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
November 27, 2012
Record last verified: 2012-11