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

• Status: Not yet recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring heparin responsiveness in adult patients undergoing cardiopulmonary bypass (CPB) for cardiac surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Octapharma
• Treatments: Antithrombin III; Antithrombins

Criteria

Inclusion Criteria:

1. Planned cardiac surgery with cardiopulmonary bypass, including any type of coronary artery bypass graft (CABG)

2. Heparin-resistant patients (pre-CPB Hemochron ACT less than 480 s in the measurement taken within 5 minutes following intravenous administration of 500 U/kg UFH)

3. Patients between 18 and 85 years of age

4. Freely given written 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. warfarin (within 3 days)

2. direct oral anticoagulants (within 2 days)

3. ticlopidine (within 14 days)

4. prasugrel (within 7 days)

5. clopidogrel (within 5 days)

6. ticagrelor (within 5 days)

7. glycoprotein IIb/IIIa antagonist (within 1 day)

2. Pre-existing coagulopathy, defined as a history of bleeding problems or a laboratory history of bleeding disorder (e.g., von Willebrand disease, platelet disorder)

3. Renal insufficiency, defined as serum creatinine level >1.5 mg/dL

4. Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ i.e., human albumin, sodium chloride, acetyl tryptophan, caprylic acid

5. History of anaphylactic reaction(s) to blood or blood components

6. Refusal to receive transfusion of blood or blood-derived products

7. Current participation in another interventional clinical trial or previous participation in the current trial

8. Treatment with any investigational product within 30 days prior to screening visit