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 (NCT06096116)
Phase 3, Double-blind, Placebo-controlled, Multicentre Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: Stanford University School of Medicine — Stanford, California
Age range: 18 Years to 85 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (27 Sites)
Showing the first 25 of 27 sites.
- Stanford University School of Medicine — Stanford, California
- University of Miami — Miami, Florida
- Massachusetts General Hospital — Boston, Massachusetts
- Duke University Medical Center — Durham, North Carolina
- Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina
- Cleveland Clinic — Cleveland, Ohio
- The Ohio State University — Columbus, Ohio
- OU Health University of Oklahoma Medical Center — Oklahoma City, Oklahoma
- University of Texas Southwestern Medical Center — Dallas, Texas
- University Hospital Innsbruck — Innsbruck,
- Vienna General Hospital AKH, Medical University of Vienna — Vienna,
- Royal Columbian Hospital — New Westminster, British Columbia
- Kingston Health Sciences Centre — Kingston, Ontario
- Toronto General Hospital — Toronto, Ontario
- Montreal Heart Institute — Montreal, Quebec
- Center of Cardiovascular and Transplant Surgery — Brno,
- Institute for Clinical and Experimental Medicine — Prague,
- CHU de Reims, Hôpital Robert Debré — Reims,
- CHU de Rennes — Rennes,
- Hospital of Lithuanian university of Health sciences Kauno Klinikos — Kaunas,
- Vilnius University hospital Santaros Klinikos — Vilnius,
- Institute for Cardiovascular Diseases C.C. Iliescu — Bucharest,
- Institute of Cardiovascular Diseases Vojvodina — Kamenitz,
- University Medical Centre Ljubljana — Ljubljana,
- Royal Papworth Hospital — Cambridge,
📞 Contact the Study Coordinator
Phone: +41 79 585 90 42
Email: Cristina.Solomon@octapharma.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Acquired Antithrombin Deficiency clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.