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

Heparin-induced Thrombocytopenia Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05783895
• Other study ID #: 2022PI190
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2023
• Source: Central Hospital, Nancy, France
• Contact: Thomas KLEIN, MD
• Phone: +3383154045
• Email: t.klein[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 1, 2023
• Est. primary completion date: March 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heparin-induced Thrombocytopenia
• Thrombocytopenia

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
France	'CHRU Nancy	Vandœuvre-lès-Nancy	Meurthe Et Moselle

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the intrinsic performance of HIT tests	To compare the intrinsic performance (sensitivity, specificity) of 4 HIT screening scores (4T, HET, GFHT, CPB) in postoperative cardiac surgery under CEC.	date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
Secondary	Evaluation of the extrinsic performance of HIT tests	To compare the extrinsic performance (sensitivity, specificity) of 4 HIT screening scores (4T, HET, GFHT, CPB) in postoperative cardiac surgery under CEC.	date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
Secondary	30-day postoperative mortality	To estimate 30-day postoperative mortality of cardiac surgery under CEC in patients with confirmed HIT.	between the date of confirmation of HIT and 30 days from the date of hospitalization