Evaluating a new treatment for patients resistant to heparin during heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 study aims to assess the efficacy and safety of Atenativ, a human plasma-derived antithrombin, in patients who are resistant to heparin and are scheduled for cardiac surgery requiring cardiopulmonary bypass. The study will compare two different doses of Atenativ against a placebo to determine its effectiveness in restoring heparin responsiveness. Eligible participants include adults aged 18 to 85 who meet specific criteria related to their heparin resistance and surgical plans. The study is designed to provide insights into improving surgical outcomes for this patient population.

Why it matters

Who can join: the full rules

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
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

Where it's running

• Stanford University School of Medicine
  Stanford, California, United States Recruiting
• University of Miami
  Miami, Florida, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Duke University Medical Center
  Durham, North Carolina, United States Recruiting
• Atrium Health Wake Forest Baptist
  Winston-Salem, North Carolina, United States Recruiting
• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: Cristina Solomon, MD
• Email: Cristina.Solomon@octapharma.com
• Phone: +41 79 585 90 42

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Assessing Atenativ for patients with congenital antithrombin deficiency during surgery or delivery

  This study tests whether Atenativ can help prevent blood clots in patients with congenital antithrombin deficiency during surgery or childbirth.

  Recruiting at 30 sites Phase 3 Octapharma · Washington D.C., District of Columbia and 29 other locations · NCT04918173

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.