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RECRUITINGPHASE3

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

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

NCT06096116•Octapharma

View on ClinicalTrials.gov

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)

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Planned cardiac surgery with CPB
•2. 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)
•3. Patients between 18 and 85 years of age, inclusive
•4. Freely given written or electronic informed consent
•5. In female patients of childbearing potential, a pre-existing negative pregnancy test within 14 days prior to surgery

Exclusion Criteria

•1. Receiving, or have received within the timeframes specified, one or more of the following medications prior to the start of surgery:
•1. vitamin K antagonists (within 3 days)
•2. direct oral anticoagulants (within 2 days)
•3. 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
•4. ticagrelor (within 5 days), unless platelet function is satisfactory according to local standard of care assessment
•5. glycoprotein IIb/IIIa antagonist (within 24 hours)
•2. Pre-existing coagulopathy, a history of bleeding problems, or a laboratory-diagnosed bleeding disorder (e.g., von Willebrand disease, platelet disorder)
•3. Renal insufficiency, defined as serum creatinine level \>2.0 mg/dL
•4. Thrombocytosis, defined as platelet count \>400,000 per μL
•5. Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ, i.e., human albumin, sodium chloride, acetyl tryptophan, caprylic acid
+4 more criteria

Locations (24)

Stanford University School of Medicine

Stanford, California, United States

University of Miami

Miami, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Duke University Medical Center

Durham, North Carolina, United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

The Ohio State University

Columbus, Ohio, United States

OU Health University of Oklahoma Medical Center

Oklahoma City, Oklahoma, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

University Hospital Innsbruck

Innsbruck, Austria

Vienna General Hospital AKH, Medical University of Vienna

Vienna, Austria

Key Dates

Start Date

August 21, 2024

Primary Completion Date

March 1, 2028

Completion Date

March 1, 2028

Last Updated

February 2, 2026

Enrollment

120

ESTIMATED participants

Conditions

Acquired Antithrombin Deficiency

Interventions

Human plasma derived antithrombin

DRUG

Placebo

DRUG

Contacts

Cristina Solomon, MD

CONTACT

+41 79 585 90 42 Cristina.Solomon@octapharma.com