NCT06096116From ClinicalTrials.govRecruiting

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

Acquired Antithrombin Deficiency

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Octapharma
Enrolment target: 120
Started: 21 August 2024
Main results due: March 2028
Study sites: 27
Registry updated: 28 September 2026

Can you take part?

Ages 18 years to 85 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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

What this study is about

In the sponsor’s own words, from the registry.

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)

Study sites(27)

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
The Ohio State University
Columbus, Ohio, United States
Recruiting
OU Health University of Oklahoma Medical Center
Oklahoma City, Oklahoma, United States
Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Recruiting
University Hospital Innsbruck
Innsbruck, Austria
Recruiting
Vienna General Hospital AKH, Medical University of Vienna
Vienna, Austria
Recruiting
Royal Columbian Hospital
New Westminster, British Columbia, Canada
Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, Canada
Recruiting
Toronto General Hospital
Toronto, Ontario, Canada
Not yet recruiting
Montreal Heart Institute
Montreal, Quebec, Canada
Recruiting
Center of Cardiovascular and Transplant Surgery
Brno, Czechia
Recruiting
Institute for Clinical and Experimental Medicine
Prague, Czechia
Terminated
CHU de Reims, Hôpital Robert Debré
Reims, France
Terminated
CHU de Rennes
Rennes, France
Withdrawn
Hospital of Lithuanian university of Health sciences Kauno Klinikos
Kaunas, Lithuania
Terminated
Vilnius University hospital Santaros Klinikos
Vilnius, Lithuania
Recruiting
Institute for Cardiovascular Diseases C.C. Iliescu
Bucharest, Romania
Recruiting
Institute of Cardiovascular Diseases Vojvodina
Kamenitz, Serbia
Recruiting
University Medical Centre Ljubljana
Ljubljana, Slovenia
Recruiting
Royal Papworth Hospital
Cambridge, United Kingdom
Recruiting
University Hospital Coventry and Warwickshire
Coventry, United Kingdom
Recruiting
The James Cook University Hospital
Middlesbrough, United Kingdom
Recruiting

Showing 27 of 27 sites. 22 of the 27 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06096116. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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