RecruitingPhase 3NCT06096116

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

Sponsor

Octapharma

Enrollment

120 participants

Start Date

Aug 21, 2024

Study Type

INTERVENTIONAL

Conditions

Acquired Antithrombin Deficiency

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)

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Human plasma derived antithrombin and a drug called Placebo for people with acquired antithrombin deficiency. The study is currently recruiting participants at 27 locations. People eligible for this study include aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHuman plasma derived antithrombin

A solvent/detergent and heat-treated antithrombin concentrate derived from human plasma

DRUGPlacebo

Half of the patients in the placebo group will be randomised to receive a volume of placebo corresponding to the low dose of Atenativ and the other half to receive a volume of placebo corresponding to a high dose of Atenativ

Locations(27)

Stanford University School of Medicine

Stanford, California, United States

University of Miami

Miami, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Duke University Medical Center

Durham, North Carolina, United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

OU Health University of Oklahoma Medical Center

Oklahoma City, Oklahoma, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

University Hospital Innsbruck

Innsbruck, Austria

Vienna General Hospital AKH, Medical University of Vienna

Vienna, Austria

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Center of Cardiovascular and Transplant Surgery

Brno, Czechia

Institute for Clinical and Experimental Medicine

Prague, Czechia

CHU de Reims, Hôpital Robert Debré

Reims, France

CHU de Rennes

Rennes, France

Hospital of Lithuanian university of Health sciences Kauno Klinikos

Kaunas, Lithuania

Vilnius University hospital Santaros Klinikos

Vilnius, Lithuania

Institute for Cardiovascular Diseases C.C. Iliescu

Bucharest, Romania

Institute of Cardiovascular Diseases Vojvodina

Kamenitz, Serbia

University Medical Centre Ljubljana

Ljubljana, Slovenia

Royal Papworth Hospital

Cambridge, United Kingdom

University Hospital Coventry and Warwickshire

Coventry, United Kingdom

The James Cook University Hospital

Middlesbrough, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06096116