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

Octapharma

Status and phase: Enrolling; Phase 3

Conditions: Acquired Antithrombin Deficiency

Treatments: Drug: Placebo; Drug: Human plasma derived antithrombin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06096116

ATN-108

Details and patient eligibility

About

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)

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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. 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, a history of bleeding problems, 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 >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 IMP within 30 days prior to screening visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups, including a placebo group

Low-dose Atenativ

Experimental group

Treatment:

Drug: Human plasma derived antithrombin

High-dose Atenativ

Experimental group

Treatment:

Drug: Human plasma derived antithrombin

Placebo

Placebo Comparator group

Description:

Patients will receive a saline bolus dose

Treatment:

Drug: Placebo