Heparin-induced Thrombocytopenia
Conditions
Brief 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. 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.
Interventions
None listed
Sponsors
Société Française d'Anesthésie et de Réanimation
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* 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
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major hemorrhagic and/or thrombotic events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cangrelor dosing modalities | intraoperative period. | Description of dose used during CPB (cardiopulmonary bypass) |
| Platelet count | from surgery to postoperative day 7. | Serial measurements |
| Hemoglobin level | from surgery to postoperative day 7. | Serial measurements |
| Fibrinogen level | from surgery to postoperative day 7. | Serial measurements |
| Prothrombin time (PT) and activated partial thromboplastin time (aPTT) | from surgery to postoperative day 7. | Serial measurements |
| Transfusion requirements | intraoperative period to postoperative day 7. | Type and number of blood products (packed red blood cells, platelets, fresh frozen plasma) and plasma-derived medicinal products administered |
| Duration of mechanical ventilation | From initiation of mechanical ventilation until successful weaning, assessed up to a maximum of 90 days | follow the duration of mechanical ventilation |
| Hospital length of stay | From date of hospital admission until date of hospital discharge, assessed up to a maximum of 90 day | follow the duration of the hospitalisation |
| In-hospital mortality | From date of hospital admission until date of hospital discharge, assessed up to a maximum of 90 day | verify if partient died or not |
Countries
France
Contacts
CONTACTAdrien BOUGLÉ, MD
Outcome results
None listed