Actively Recruiting
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
Led by Octapharma · Updated on 2026-05-12
120
Participants Needed
27
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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)
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Planned cardiac surgery requiring cardiopulmonary bypass
- Heparin-resistant patients with specific blood clotting test results after heparin use
- Age between 18 and 85 years inclusive
- Provided freely given written or electronic informed consent
- For women of childbearing potential, a negative pregnancy test within 14 days before surgery
You will not qualify if you...
- Use of certain blood-thinning medications within specified timeframes before surgery (vitamin K antagonists, direct oral anticoagulants, thienopyridines, ticagrelor, glycoprotein IIb/IIIa antagonists)
- Pre-existing bleeding disorders or a history of bleeding problems
- Renal insufficiency with serum creatinine level above 2.0 mg/dL
- High platelet count above 400,000 per microliter
- Known allergy to antithrombin or any components of Atenativ
- History of severe allergic reactions to blood or blood products
- Refusal to receive blood transfusions or blood-derived products
- Participation in another interventional clinical trial currently or previously in this trial
- Treatment with any investigational medicinal product within 30 days before screening visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
Stanford University School of Medicine
Stanford, California, United States, 94305-5101
Actively Recruiting
2
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
4
Duke University Medical Center
Durham, North Carolina, United States, 27710-1000
Actively Recruiting
5
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
6
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
7
The Ohio State University
Columbus, Ohio, United States, 43214
Actively Recruiting
8
OU Health University of Oklahoma Medical Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
9
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
10
University Hospital Innsbruck
Innsbruck, Austria
Actively Recruiting
11
Vienna General Hospital AKH, Medical University of Vienna
Vienna, Austria
Actively Recruiting
12
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L0A4
Actively Recruiting
13
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L2V7
Actively Recruiting
14
Toronto General Hospital
Toronto, Ontario, Canada, M5G2C4
Actively Recruiting
15
Montreal Heart Institute
Montreal, Quebec, Canada, H1T1C8
Actively Recruiting
16
Center of Cardiovascular and Transplant Surgery
Brno, Czechia
Actively Recruiting
17
Institute for Clinical and Experimental Medicine
Prague, Czechia
Actively Recruiting
18
CHU de Reims, Hôpital Robert Debré
Reims, France
Terminated
19
CHU de Rennes
Rennes, France
Withdrawn
20
Hospital of Lithuanian university of Health sciences Kauno Klinikos
Kaunas, Lithuania
Actively Recruiting
21
Vilnius University hospital Santaros Klinikos
Vilnius, Lithuania
Actively Recruiting
22
Institute for Cardiovascular Diseases C.C. Iliescu
Bucharest, Romania
Actively Recruiting
23
Institute of Cardiovascular Diseases Vojvodina
Kamenitz, Serbia
Not Yet Recruiting
24
University Medical Centre Ljubljana
Ljubljana, Slovenia
Actively Recruiting
25
Royal Papworth Hospital
Cambridge, United Kingdom
Actively Recruiting
26
University Hospital Coventry and Warwickshire
Coventry, United Kingdom
Actively Recruiting
27
The James Cook University Hospital
Middlesbrough, United Kingdom
Actively Recruiting
Research Team
C
Cristina Solomon, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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