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NCT Number: NCT07817680

Cangrelor As Treatment for Cardiac Surgery Associated With Heparin Induced Thrombocytopenia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Universitaire La Pitié-Salpêtrière

Paris, 75013, France

Location contact

Adrien Bouglé, MD

CONTACT

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Cangrelor dosing modalities

    Time frame: intraoperative period.

    Description of dose used during CPB (cardiopulmonary bypass)

  2. Cangrelor dosing modalities

    Time frame: intraoperative period.

    Description monitoring during CPB (cardiopulmonary bypass)

  3. Cangrelor dosing modalities

    Time frame: intraoperative period.

    Description of dose adjustments during CPB (cardiopulmonary bypass)

  4. Cangrelor dosing modalities

    Time frame: intraoperative period.

    Description of duration of drug during CPB (cardiopulmonary bypass)

  5. Platelet count

    Time frame: from surgery to postoperative day 7.

    Serial measurements

  6. Hemoglobin level

    Time frame: from surgery to postoperative day 7.

    Serial measurements

  7. Fibrinogen level

    Time frame: from surgery to postoperative day 7.

    Serial measurements

  8. Prothrombin time (PT) and activated partial thromboplastin time (aPTT)

    Time frame: from surgery to postoperative day 7.

    Serial measurements

  9. Transfusion requirements

    Time frame: 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

  10. Duration of mechanical ventilation

    Time frame: From initiation of mechanical ventilation until successful weaning, assessed up to a maximum of 90 days

    follow the duration of mechanical ventilation

  11. Hospital length of stay

    Time frame: From date of hospital admission until date of hospital discharge, assessed up to a maximum of 90 day

    follow the duration of the hospitalisation

  12. In-hospital mortality

    Time frame: From date of hospital admission until date of hospital discharge, assessed up to a maximum of 90 day

    verify if partient died or not

Study contacts

Contact information is provided by the study sponsor or research team.

Adrien BOUGLÉ, MD

CONTACT

[email protected]

+33 1 42 16 29 91

Sponsors and collaborators

Lead sponsor

Société Française d'Anesthésie et de Réanimation

Other

Registry information

Acronym: CATCH-IT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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