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NCT06096116 | RECRUITING | Acquired Antithrombin Deficiency

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
Sponsor:

Octapharma

Brief Summary:

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 or disease

Acquired Antithrombin Deficiency

Intervention/treatment

Human plasma derived antithrombin

Placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : TRIPLE
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.
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2024-08-21
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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, 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. 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
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

Location Details

NCT06096116

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, California

Stanford University School of Medicine

Stanford, California, United States, 94305-5101

NOT YET RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

RECRUITING

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710-1000

RECRUITING

United States, North Carolina

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States, 27157

NOT YET RECRUITING

United States, Ohio

The Ohio State University

Columbus, Ohio, United States, 43214

RECRUITING

United States, Oklahola

OU Health University of Oklahoma Medical Center

Ololama City, Okholohan, United States, 73104

NOT YET RECRUITING

United States, Texas

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

RECRUITING

Austria,

University Hospital Innsbruck

Innsbruck, Austria,

NOT YET RECRUITING

Austria,

Vienna General Hospital AKH, Medical University of Vienna

Vienna, Austria,

RECRUITING

Czechia,

Center of Cardiovascular and Transplant Surgery

Brno, Czechia,

NOT YET RECRUITING

Czechia,

Institute for Clinical and Experimental Medicine

Prague, Czechia,

NOT YET RECRUITING

France,

CHU de Reims, Robert Debré Hospital

Reims, France,

RECRUITING

France,

Rennes of Chu

Rennes, France,

RECRUITING

Lithuania,

Hospital of Lithuanian university of Health sciences Kauno Klinikos

Kaunas, Lithuania,

NOT YET RECRUITING

Lithuania,

Vilnius University Hospital Santara Clinic

Vilnius, Lithuania,

RECRUITING

Romania,

Institute for Cardiovascular Diseases C.C. Iliescu

Bucharest, Romania,

RECRUITING

Slovenia,

University Medical Centre Ljubljana

Ljubljana, Slovenia,

RECRUITING

United Kingdom,

Royal Papworth Hospital

Cambridge, United Kingdom,