Rapid Diagnosis of Heparin-Induced Thrombocytopenia in Surgical Critically Ill Patients (TIH)

Centre Hospitalier Universitaire de Besancon

Status: Completed

Conditions: Heparin-induced Thrombocytopenia (HIT)

Treatments: Other: HEP score; Other: HIT-Ab(PF4-H) test; Other: ID-PaGIA test; Other: 4Ts score

Study type: Observational

Funder types: Other

Identifiers

NCT02790567

TIH-2012

Details and patient eligibility

About

The early diagnosis of heparin-induced thrombocytopenia is particularly difficult in surgical critically ill patients. If the use of rapid immunological diagnostic methods and pretest scoring systems has been proposed in the medical intensive care unit (ICU), none of these methods have been specifically evaluated in the diagnosis of HIT in surgical patients.

Full description

Heparin-induced thrombocytopenia (HIT) is of concern in critically ill patients, given the high prevalence of heparin use. The diagnosis of HIT in surgical intensive care unit (ICU) is problematic due to the lack of reliable diagnostic method. No gold standard currently exists and the definitive diagnosis is mainly based on the detection of heparin-dependent platelet-activating antibodies by ELISA method, on the platelet serotonin release assay (SRA) and on the changes of the blood platelet count after the discontinuation of heparin therapy. As a result, no early definitive diagnosis could be done. This could expose patients to thrombotic complications related to the HIT or hemorrhagic complications related to the alternative anticoagulant prescribed. This complications can threaten the prognosis of these patients. Particle gel immunoassay and automated immunoassay has been proposed for the early diagnosis of HIT in medical critically ill and non-critically ill patients. Many authors suggest that the accuracy of these immunological methods for the diagnosis of HIT could be altered in surgical patients, but these tests has never been specifically evaluated in this population. The 4Ts and the HIT Expert Probability (HEP) score systems sound interesting for the diagnosis of HIT. These clinicobiological scores can be easily used by non-expert clinicians, but have also never been evaluated in the surgical ICU.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years old
• Diagnosis of HIT suspected
• Admitted in our surgical intensive care unit during the study period

Exclusion criteria

• Age < 18 years old
• Pregnancy and/or breast feeding
• Fondaparinux anticoagulation
• Withdrawal of consent

Trial design

120 participants in 1 patient group

HIT study group

Description:

The HIT study group will include all patients admitted in our surgical intensive care unit (ICU) during the study period if the clinician in charge of the patient suspects the diagnosis of HIT. The HEP score, the 4Ts score, the immuno-diffusion particle gel immunoassay (ID-PaGIA) and the HIT-Ab(PF4-H) test will be done for each patient the day the diagnosis of HIT will be suspected.

Treatment:

Other: ID-PaGIA test

Other: 4Ts score

Other: HIT-Ab(PF4-H) test

Other: HEP score