Comparison of Pre-test Probability Model for Heparin-induced Thrombocytopenia in Post-operative Cardiac Surgery

NCT ID: NCT05783895

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2023-06-01

Brief Summary

Heparin-induced thrombocytopenia (HIT) is a pro-thrombotic immunological condition that occurs in some patients exposed to heparin. The incidence of HIT is estimated at 0.1 to 0.3% of patients exposed to heparin, and rises to 3% in postoperative cardiac surgery. Cardiac surgery under CEC requires the use of high doses of heparin, which contributes to the increased incidence of HIT in this population. This high incidence is also explained by the comorbid profile of cardiac surgery patients, who often present risk factors for HIT (perioperative context, atrial fibrillation, organ failure, previous exposure to heparin, etc.). When it occurs postoperatively in cardiac surgery, there is a 28% increase in mortality, a 50% increase in morbidity, and an increase in hospitalization costs and length of stay. Although usually detected in medical wards on the basis of probability scores (4T, HEP), its diagnosis is less easy in postoperative cardiac surgery. Because of the many differential diagnoses, the screening scores usually used are less effective, and HIT is often diagnosed late, in patients who may have already developed a thromboembolic complication, which sometimes proves fatal. In addition, the diagnostic tests for HIT are compromised and lose their sensitivity in postoperative cardiac surgery, given the high incidence of seroconversion observed after extracorporeal circulation. Indeed, more than 50% of patients have antibodies to PF4/heparin, but only 1 to 2% of them have true HIT.These elements highlight the need to develop effective screening scores for HIT in postoperative cardiac surgery, given the complications to which patients are exposed in the event of underdiagnosis but also in the event of overdiagnosis. Other screening scores are being studied, not yet validated in cardiac surgery, such as the CPB score or the GFHT score. Early recognition of HIT would reduce the morbidity and mortality associated with this condition.

The present study should make it possible to identify the most effective HIT probability score among those used in routine screening and thus to orient towards screening for this condition as early as possible, and consequently reduce the associated morbidity.

Conditions

Heparin-induced Thrombocytopenia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Confirmed HIT

Comprehensive collection of patients with suspected and then proven HIT postoperatively from cardiac surgery with bypass surgery during the inclusion period.

Post screening diagnostic test

Intervention Type: DIAGNOSTIC_TEST

1\) anti-PF4/heparin antibody test (ELISA) and 2) in vitro platelet aggregation tests. The diagnosis of HIT is made when both tests are positive or when a platelet aggregation test is positive.

Absence of HIT

Patients with suspected and unconfirmed HIT postoperatively from cardiac surgery under CEC during the inclusion period.

Post screening diagnostic test

Intervention Type: DIAGNOSTIC_TEST

1\) anti-PF4/heparin antibody test (ELISA) and 2) in vitro platelet aggregation tests. The diagnosis of HIT is made when both tests are positive or when a platelet aggregation test is positive.

Interventions

Post screening diagnostic test

1\) anti-PF4/heparin antibody test (ELISA) and 2) in vitro platelet aggregation tests. The diagnosis of HIT is made when both tests are positive or when a platelet aggregation test is positive.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Major patients, who underwent cardiac surgery with cardiopulmonarybypass between 01/01/2010 and 12/31/2021, in whom HIT was suspected postoperatively.

Exclusion Criteria

• Patients with known preoperative HIT,
• cardiac surgery patients without bypass surgery,
• diagnostic tests for HIT not performed.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas KLEIN, MD

Role: STUDY_DIRECTOR

Nancy Hospital

Locations

'CHRU Nancy

Vandœuvre-lès-Nancy, Meurthe Et Moselle, France

Site Status: RECRUITING

Countries

France

Central Contacts

Thomas KLEIN, MD

Role: CONTACT

t.klein@chru-nancy.fr

+3383154045

Facility Contacts

KLEIN Thomas, MD

Role: primary

t.klein@chru-nancy.fr

+33383154045

Other Identifiers

2022PI190

Identifier Type: -

Identifier Source: org_study_id