Status:
RECRUITING
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
Lead Sponsor:
Octapharma
Conditions:
Acquired Antithrombin Deficiency
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief 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 car...
Eligibility Criteria
Inclusion
- 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
- 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
- glycoprotein IIb/IIIa antagonist (within 24 hours)
- Pre-existing coagulopathy, a history of bleeding problems, a history of bleeding problems, or a laboratory-diagnosed bleeding disorder (e.g., von Willebrand disease, platelet disorder)
- Renal insufficiency, defined as serum creatinine level \>2.0 mg/dL
- Thrombocytosis, defined as platelet count \>400,000 per μL
- Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ i.e., human albumin, sodium chloride, acetyl tryptophan, caprylic acid
- History of anaphylactic reaction(s) to blood or blood components
- Refusal to receive transfusion of blood or blood-derived products
- Current participation in another interventional clinical trial or previous participation in the current trial
- Treatment with any IMP within 30 days prior to screening visit
Key Trial Info
Start Date :
August 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06096116
Start Date
August 21 2024
End Date
March 1 2028
Last Update
October 3 2025
Active Locations (22)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305-5101
2
University of Miami
Miami, Florida, United States, 33136
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Duke University Medical Center
Durham, North Carolina, United States, 27710-1000