Heparin-induced ThrombocytopeniaTicTacNCT05783895
Comparison of Pre-test Probability Model for Heparin-induced Thrombocytopenia in Post-operative Cardiac Surgery
An observational study of Heparin-induced Thrombocytopenia, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heparin-induced Thrombocytopenia
- What is being tested?
- Post screening diagnostic test
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2023to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study concerns patients over 18 years of age, undergoing scheduled or emergency cardiac surgery with postoperative thrombocytopenia and suspected HIT.
Who may be able to join
- Major patients, who underwent cardiac surgery with cardiopulmonarybypass between 01/01/2010 and 12/31/2021, in whom HIT was suspected postoperatively.
Who cannot join
- Patients with known preoperative HIT,
- cardiac surgery patients without bypass surgery,
- diagnostic tests for HIT not performed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
'CHRU Nancy
Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54530
KLEIN Thomas, MD, +33383154045, t.klein@chru-nancy.fr
About this study
Official title: 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.
- Conditions
- Heparin-induced Thrombocytopenia
- Being tested
- Post screening diagnostic test
- Keywords
- Cardiopulmonary Bypass, pre-test probability model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post screening diagnostic testDiagnostic test
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Confirmed HIT | Comprehensive collection of patients with suspected and then proven HIT postoperatively from cardiac surgery with bypass surgery during the inclusion period. Receives: Diagnostic Test: Post screening diagnostic test | |
| Absence of HIT | Patients with suspected and unconfirmed HIT postoperatively from cardiac surgery under CEC during the inclusion period. Receives: Diagnostic Test: Post screening diagnostic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
Secondary outcomes (2)
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.
Measured: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
30-day postoperative mortality
To estimate 30-day postoperative mortality of cardiac surgery under CEC in patients with confirmed HIT.
Measured: between the date of confirmation of HIT and 30 days from the date of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 Mar 2023
- Primary completion2 Mar 2023
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heparin-induced ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas KLEIN, MD, Study director, Nancy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783895
- Sponsor's protocol ID
- 2022PI190
- Acronym
- TicTac
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2023
- Last updated
- 24 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pre-test Probability Model for Heparin-induced Thrombocytopenia in Post-operative Cardiac Surgery With Bypass Surgery
- ClinicalTrials.gov ID
- NCT05783895
- Acronym / sponsor ID
- TicTac / 2022PI190
- Conditions
- Heparin-induced Thrombocytopenia
- Keywords
- Cardiopulmonary Bypass, pre-test probability model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Confirmed HIT | – | Diagnostic Test: Post screening diagnostic testComprehensive collection of patients with suspected and then proven HIT postoperatively from cardiac surgery with bypass surgery during the inclusion period. |
| Absence of HIT | – | Diagnostic Test: Post screening diagnostic testPatients with suspected and unconfirmed HIT postoperatively from cardiac surgery under CEC during the inclusion period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study concerns patients over 18 years of age, undergoing scheduled or emergency cardiac surgery with postoperative thrombocytopenia and suspected HIT.
Key inclusion criteria (1 listed)
- Major patients, who underwent cardiac surgery with cardiopulmonarybypass between 01/01/2010 and 12/31/2021, in whom HIT was suspected postoperatively.
Key exclusion criteria (3 listed)
- Patients with known preoperative HIT,
- cardiac surgery patients without bypass surgery,
- diagnostic tests for HIT not performed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post screening diagnostic test1) 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. | Diagnostic test | Absence of HIT, Confirmed HIT |
Primary outcome
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.
2 secondary outcomes
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
30-day postoperative mortality
Time frame: between the date of confirmation of HIT and 30 days from the date of hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Heparin-induced Thrombocytopenia
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Characterization and Quantification of Platelet/Leukocyte Aggregates in Patients With Suspected Heparin-induced Thrombocytopenia
Heparin-induced Thrombocytopenia, HIT
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas KLEIN, MD study director
Nancy Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heparin-induced Thrombocytopenia, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas KLEIN, MD (+3383154045, t.klein@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.