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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Acquired Antithrombin Deficiency

In brief

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)

Key facts

Study ID

NCT06096116

Run by

Octapharma

People needed

120

Starts

2024-08-21

Expected to finish

2028-03-01

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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, 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

Where it is running

• The James Cook University Hospital — Middlesbrough, United Kingdom (enrolling)
• University of Miami — Miami, Florida, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (enrolling)
• University Medical Centre Ljubljana — Ljubljana, Slovenia (enrolling)
• Royal Papworth Hospital — Cambridge, United Kingdom (enrolling)
• University Hospital Coventry and Warwickshire — Coventry, United Kingdom (enrolling)
• Stanford University School of Medicine — Stanford, California, United States (enrolling)
• The Ohio State University — Columbus, Ohio, United States (enrolling)
• OU Health University of Oklahoma Medical Center — Oklahoma City, Oklahoma, United States (enrolling)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• University Hospital Innsbruck — Innsbruck, Austria (enrolling)
• Vienna General Hospital AKH, Medical University of Vienna — Vienna, Austria (enrolling)
• Royal Columbian Hospital — New Westminster, British Columbia, Canada (enrolling)
• Kingston Health Sciences Centre — Kingston, Ontario, Canada (enrolling)
• Toronto General Hospital — Toronto, Ontario, Canada (enrolling)
• Montreal Heart Institute — Montreal, Quebec, Canada (enrolling)
• Center of Cardiovascular and Transplant Surgery — Brno, Czechia (enrolling)
• Institute for Clinical and Experimental Medicine — Prague, Czechia (enrolling)
• Hospital of Lithuanian university of Health sciences Kauno Klinikos — Kaunas, Lithuania (enrolling)
• Vilnius University hospital Santaros Klinikos — Vilnius, Lithuania (enrolling)
• Institute for Cardiovascular Diseases C.C. Iliescu — Bucharest, Romania (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States
• CHU de Rennes — Rennes, France

Full record on ClinicalTrials.gov

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