Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Hepar… (NCT06096116) | Clinical Trial Compass
RecruitingPhase 3
Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass
United States120 participantsStarted 2024-08-21
Plain-language summary
The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating cardiopulmonary bypass (CPB)
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Planned cardiac surgery with CPB
✓. Heparin-resistant patients (pre-CPB Hemochron ACT less than 480 s in the measurement taken between 2-5 minutes following intravenous administration of 500 U/kg UFH)
✓. Patients between 18 and 85 years of age, inclusive
✓. Freely given written or electronic informed consent
✓. In female patients of childbearing potential, a pre-existing negative pregnancy test within 14 days prior to surgery
Exclusion criteria
✕. Receiving, or have received within the timeframes specified, one or more of the following medications prior to the start of surgery:
✕. vitamin K antagonists (within 3 days)
✕. direct oral anticoagulants (within 2 days)
✕. thienopyridines (ticlopidine within 14 days, prasugrel within 7 days, or clopidogrel within 5 days), unless platelet function is satisfactory according to local standard of care assessment
✕. ticagrelor (within 5 days), unless platelet function is satisfactory according to local standard of care assessment
✕. Pre-existing coagulopathy, a history of bleeding problems, or a laboratory-diagnosed bleeding disorder (e.g., von Willebrand disease, platelet disorder)
What they're measuring
1
Restoring heparin responsiveness
Timeframe: During surgery (from the time of the first surgical incision to the time at which the final suture or staple is placed)