Comparison of Pre-test Probability Model for Heparin-induced Thrombocytopenia in Post-operative Cardiac Surgery (TicTac)
Comparison of Pre-test Probability Model for Heparin-induced Thrombocytopenia in Post-operative Cardiac Surgery With Bypass Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Thomas KLEIN, MD
- Phone Number: +3383154045
- Email: t.klein@chru-nancy.fr
Study Locations
-
-
Meurthe Et Moselle
-
Vandœuvre-lès-Nancy, Meurthe Et Moselle, France, 54530
- Recruiting
- 'CHRU Nancy
-
Contact:
- KLEIN Thomas, MD
- Phone Number: +33383154045
- Email: t.klein@chru-nancy.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Confirmed HIT
Comprehensive collection of patients with suspected and then proven HIT postoperatively from cardiac surgery with bypass surgery during the inclusion period.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of the intrinsic performance of HIT tests
Time Frame: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of the extrinsic performance of HIT tests
Time Frame: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
|
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
|
|
30-day postoperative mortality
Time Frame: between the date of confirmation of HIT and 30 days from the date of hospitalization
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Thomas KLEIN, MD, NANCY HOSPITAL
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022PI190
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.