Heparin-induced ThrombocytopeniaCATCH-ITNCT07817680
Cangrelor As Treatment for Cardiac Surgery Associated With Heparin Induced Thrombocytopenia
An observational study of Heparin-induced Thrombocytopenia, run by Société Française d'Anesthésie et de Réanimation at 1 site in France.
Trial summary
Heparin-induced thrombocytopenia (HIT) is a rare but serious immune complication of heparin exposure that paradoxically increases the risk of thrombosis. In patients undergoing cardiac surgery with cardiopulmonary bypass (CPB), heparin is essential to prevent circuit clotting, yet contraindicated in HIT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heparin-induced Thrombocytopenia
- How many people
- 132 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2026to 1 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: * Age < 18 years * HIT not confirmed or ruled out * Patient objection to data use * Surgery performed without CPB * Requirement for continued cangrelor in the postoperative period * Post-cardiotomy ECMO
Who may be able to join
- Age ≥ 18 years
- Confirmed or highly probable HIT: 4T score ≥ 3 AND positive anti-PF4 antibodies (ELISA or equivalent), and when available, positive functional platelet test
- Cardiac or aortic surgery with cardiopulmonary bypass (CPB)
- Cangrelor administered in the perioperative period
- No objection to use of medical data
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Universitaire La Pitié-Salpêtrière
Paris, 75013
Adrien Bouglé, MD
About this study
Heparin-induced thrombocytopenia (HIT) is a rare but serious immune complication of heparin exposure that paradoxically increases the risk of thrombosis. In patients undergoing cardiac surgery with cardiopulmonary bypass (CPB), heparin is essential to prevent circuit clotting, yet contraindicated in HIT. Available alternatives carry significant limitations. Cangrelor, an intravenous reversible P2Y12 inhibitor, has shown promise in case reports and small series in this context, but no multicenter study exists. CATCH-IT is a multicenter retrospective observational study conducted across 11 French cardiac surgery centers, aiming to describe the safety and efficacy of cangrelor combined with heparin during CPB in confirmed HIT patients, by estimating the incidence of major bleeding and thrombotic events within 7 days after surgery.
Read the detailed description
Heparin-induced thrombocytopenia (HIT) is an immunological complication characterized by thrombocytopenia and a paradoxical pro-thrombotic state due to anti-platelet factor 4 (anti-PF4) antibodies. In patients requiring cardiopulmonary bypass (CPB), anticoagulation management is particularly challenging: unfractionated heparin is essential to prevent circuit thrombosis, yet its use is contraindicated when anti-PF4 antibodies are present. Alternative anticoagulants (bivalirudin, argatroban, danaparoid) carry important limitations including slow kinetics, absence of a reversal agent, high bleeding risk, and elevated cost.
Cangrelor, an intravenous reversible P2Y12 receptor inhibitor, offers rapid onset of action, full reversibility upon discontinuation, and no interaction with anti-PF4 antibodies. Its use during CPB in HIT patients has been reported in case reports and small series with favorable outcomes. However, no multicenter retrospective cohort study has yet characterized its real-world use, efficacy, or safety profile in this clinical context.
Given the low incidence of HIT in cardiac surgery and the complexity of the perioperative setting, a prospective randomized trial is not feasible. A multicenter retrospective study is therefore the most appropriate methodology to achieve sufficient sample size and reliably describe practice patterns, cangrelor dosing modalities, and thromboembolic and hemorrhagic complication profiles.
CATCH-IT will collect standardized data from existing medical records at 11 participating centers in France, covering patients operated between 2020 and 2025. No additional procedures or modifications to standard care are performed.
- Conditions
- Heparin-induced Thrombocytopenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major hemorrhagic and/or thrombotic events
Proportion of patients experiencing at least one major hemorrhagic event (BARC grade ≥3, including hemoglobin drop ≥3 g/dL, red blood cell transfusion attributed to bleeding, need for interventional procedure, hemorrhagic shock, or documented intracranial hemorrhage) and/or thrombotic complication (imaging-confirmed ischemic stroke, acute mesenteric ischemia requiring surgery, acute limb ischemia, or vascular thrombosis) within 7 days after surgery.
Measured: 7 days postoperatively
Secondary outcomes (12)
Cangrelor dosing modalities
Description of dose used during CPB (cardiopulmonary bypass)
Measured: intraoperative period.
Cangrelor dosing modalities
Description monitoring during CPB (cardiopulmonary bypass)
Measured: intraoperative period.
Cangrelor dosing modalities
Description of dose adjustments during CPB (cardiopulmonary bypass)
Measured: intraoperative period.
Cangrelor dosing modalities
Description of duration of drug during CPB (cardiopulmonary bypass)
Measured: intraoperative period.
Platelet count
Serial measurements
Measured: from surgery to postoperative day 7.
Hemoglobin level
Serial measurements
Measured: from surgery to postoperative day 7.
Fibrinogen level
Serial measurements
Measured: from surgery to postoperative day 7.
Prothrombin time (PT) and activated partial thromboplastin time (aPTT)
Serial measurements
Measured: from surgery to postoperative day 7.
Transfusion requirements
Type and number of blood products (packed red blood cells, platelets, fresh frozen plasma) and plasma-derived medicinal products administered
Measured: intraoperative period to postoperative day 7.
Duration of mechanical ventilation
follow the duration of mechanical ventilation
Measured: From initiation of mechanical ventilation until successful weaning, assessed up to a maximum of 90 days
Hospital length of stay
follow the duration of the hospitalisation
Measured: From date of hospital admission until date of hospital discharge, assessed up to a maximum of 90 day
In-hospital mortality
verify if partient died or not
Measured: From date of hospital admission until date of hospital discharge, assessed up to a maximum of 90 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Feb 2028 (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.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société Française d'Anesthésie et de Réanimation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817680
- Sponsor's protocol ID
- SFAR 2026-03
- Acronym
- CATCH-IT
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cangrelor As Treatment for Cardiac Surgery Associated With Heparin Induced Thrombocytopenia
- ClinicalTrials.gov ID
- NCT07817680
- Acronym / sponsor ID
- CATCH-IT / SFAR 2026-03
- Conditions
- Heparin-induced Thrombocytopenia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Société Française d'Anesthésie et de RéanimationUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 14 Sep 2026 (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 rare but serious immune complication of heparin exposure that paradoxically increases the risk of thrombosis. In patients undergoing cardiac surgery with cardiopulmonary bypass (CPB), heparin is essential to prevent circuit clotting, yet contraindicated in HIT. Available alternatives carry significant limitations. Cangrelor, an intravenous reversible P2Y12 inhibitor, has shown promise in case reports and small series in this context, but no multicenter study exists. CATCH-IT is a multicenter retrospective observational study conducted across 11 French cardiac surgery centers, aiming to describe the safety and efficacy of cangrelor combined with heparin during CPB in confirmed HIT patients, by estimating the incidence of major bleeding and thrombotic events within 7 days after surgery.
Detailed description
Heparin-induced thrombocytopenia (HIT) is an immunological complication characterized by thrombocytopenia and a paradoxical pro-thrombotic state due to anti-platelet factor 4 (anti-PF4) antibodies. In patients requiring cardiopulmonary bypass (CPB), anticoagulation management is particularly challenging: unfractionated heparin is essential to prevent circuit thrombosis, yet its use is contraindicated when anti-PF4 antibodies are present. Alternative anticoagulants (bivalirudin, argatroban, danaparoid) carry important limitations including slow kinetics, absence of a reversal agent, high bleeding risk, and elevated cost.
Cangrelor, an intravenous reversible P2Y12 receptor inhibitor, offers rapid onset of action, full reversibility upon discontinuation, and no interaction with anti-PF4 antibodies. Its use during CPB in HIT patients has been reported in case reports and small series with favorable outcomes. However, no multicenter retrospective cohort study has yet characterized its real-world use, efficacy, or safety profile in this clinical context.
Given the low incidence of HIT in cardiac surgery and the complexity of the perioperative setting, a prospective randomized trial is not feasible. A multicenter retrospective study is therefore the most appropriate methodology to achieve sufficient sample size and reliably describe practice patterns, cangrelor dosing modalities, and thromboembolic and hemorrhagic complication profiles.
CATCH-IT will collect standardized data from existing medical records at 11 participating centers in France, covering patients operated between 2020 and 2025. No additional procedures or modifications to standard care are performed.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * Age < 18 years * HIT not confirmed or ruled out * Patient objection to data use * Surgery performed without CPB * Requirement for continued cangrelor in the postoperative period * Post-cardiotomy ECMO
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Confirmed or highly probable HIT: 4T score ≥ 3 AND positive anti-PF4 antibodies (ELISA or equivalent), and when available, positive functional platelet test
- Cardiac or aortic surgery with cardiopulmonary bypass (CPB)
- Cangrelor administered in the perioperative period
- No objection to use of medical data
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of major hemorrhagic and/or thrombotic events
Time frame: 7 days postoperatively
Proportion of patients experiencing at least one major hemorrhagic event (BARC grade ≥3, including hemoglobin drop ≥3 g/dL, red blood cell transfusion attributed to bleeding, need for interventional procedure, hemorrhagic shock, or documented intracranial hemorrhage) and/or thrombotic complication (imaging-confirmed ischemic stroke, acute mesenteric ischemia requiring surgery, acute limb ischemia, or vascular thrombosis) within 7 days after surgery.
12 secondary outcomes
Cangrelor dosing modalities
Time frame: intraoperative period.
Cangrelor dosing modalities
Time frame: intraoperative period.
Cangrelor dosing modalities
Time frame: intraoperative period.
Cangrelor dosing modalities
Time frame: intraoperative period.
Platelet count
Time frame: from surgery to postoperative day 7.
Hemoglobin level
Time frame: from surgery to postoperative day 7.
Fibrinogen level
Time frame: from surgery to postoperative day 7.
Prothrombin time (PT) and activated partial thromboplastin time (aPTT)
Time frame: from surgery to postoperative day 7.
Transfusion requirements
Time frame: intraoperative period to postoperative day 7.
Duration of mechanical ventilation
Time frame: From initiation of mechanical ventilation until successful weaning, assessed up to a maximum of 90 days
Hospital length of stay
Time frame: From date of hospital admission until date of hospital discharge, assessed up to a maximum of 90 day
In-hospital mortality
Time frame: From date of hospital admission until date of hospital discharge, assessed up to a maximum of 90 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
Related trials for Heparin-induced Thrombocytopenia
Recruiting
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.
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 Société Française d'Anesthésie et de Réanimation 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 5 inclusion and 1 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: opening soon, as of the sponsor's last update on 14 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adrien BOUGLÉ, MD (+33 1 42 16 29 91, adrien.bougle@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major hemorrhagic and/or thrombotic events (time frame: 7 days postoperatively). 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 14 Sep 2026.