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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00748839

Acronym

Score-TIH

Enrollment

2700

Registered

2008-09-09

Start date

2009-03-31

Completion date

2012-11-30

Last updated

2012-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heparin-induced Thrombocytopenia

Keywords

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

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
pathogenic nature of anti HPF4 antibodies of IgM and IgA type	inclusion
new biological test detecting HIT	inclusion

Countries

France

Outcome results