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
Purpose
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)
Condition
- Acquired Antithrombin Deficiency
Eligibility
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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 6. History of anaphylactic reaction(s) to blood or blood components 7. Refusal to receive transfusion of blood or blood-derived products 8. Current participation in another interventional clinical trial or previous participation in the current trial 9. Treatment with any IMP within 30 days prior to screening visit
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
- Masking Description
- Triple (Participant, Care Provider, Outcomes Assessor) The patients, care provider administering IMP, and outcomes assessors will be blinded from treatment allocations. Delegated study personnel preparing the IMP will be unblinded.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Low-dose Atenativ |
Patients will receive a single bolus of 30 international units (IU)/kg body weight (BW) Atenativ. |
|
|
Experimental High-dose Atenativ |
Patients will receive a single bolus of 60 international units (IU)/kg body weight (BW) Atenativ. |
|
|
Placebo Comparator Placebo |
Patients will receive a saline bolus dose |
|
Recruiting Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Octapharma