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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05783895
Acronym
TicTac
Enrollment
200
Registered
2023-03-24
Start date
2023-03-01
Completion date
2023-06-01
Last updated
2023-03-24

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

Conditions

Heparin-induced Thrombocytopenia

Keywords

Cardiopulmonary Bypass, pre-test probability model

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.

Interventions

DIAGNOSTIC_TESTPost 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.

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the intrinsic performance of HIT testsdate of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 monthsTo compare the intrinsic performance (sensitivity, specificity) of 4 HIT screening scores (4T, HET, GFHT, CPB) in postoperative cardiac surgery under CEC.

Secondary

MeasureTime frameDescription
Evaluation of the extrinsic performance of HIT testsdate of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 monthsTo compare the extrinsic performance (sensitivity, specificity) of 4 HIT screening scores (4T, HET, GFHT, CPB) in postoperative cardiac surgery under CEC.
30-day postoperative mortalitybetween the date of confirmation of HIT and 30 days from the date of hospitalizationTo estimate 30-day postoperative mortality of cardiac surgery under CEC in patients with confirmed HIT.

Countries

France

Contacts

Primary ContactThomas KLEIN, MD
t.klein@chru-nancy.fr+3383154045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026