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

PHASE3RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

August 21, 2024

Primary Completion Date

March 31, 2028

Study Completion Date

March 31, 2028

Conditions
Acquired Antithrombin Deficiency
Interventions
DRUG

Human plasma derived antithrombin

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

DRUG

Placebo

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

Trial Locations (22)

27157

RECRUITING

Atrium Health Wake Forest Baptist, Winston-Salem

33136

NOT_YET_RECRUITING

University of Miami, Miami

43214

RECRUITING

The Ohio State University, Columbus

73104

RECRUITING

OU Health University of Oklahoma Medical Center, Oklahoma City

75390

RECRUITING

University of Texas Southwestern Medical Center, Dallas

94305-5101

RECRUITING

Stanford University School of Medicine, Stanford

02114

NOT_YET_RECRUITING

Massachusetts General Hospital, Boston

27710-1000

RECRUITING

Duke University Medical Center, Durham

Unknown

RECRUITING

University Hospital Innsbruck, Innsbruck

RECRUITING

Vienna General Hospital AKH, Medical University of Vienna, Vienna

RECRUITING

Center of Cardiovascular and Transplant Surgery, Brno

RECRUITING

Institute for Clinical and Experimental Medicine, Prague

RECRUITING

CHU de Reims, Hôpital Robert Debré, Reims

RECRUITING

CHU de Rennes, Rennes

RECRUITING

Hospital of Lithuanian university of Health sciences Kauno Klinikos, Kaunas

RECRUITING

Institute for Cardiovascular Diseases C.C. Iliescu, Bucharest

RECRUITING

University Medical Centre Ljubljana, Ljubljana

RECRUITING

Royal Papworth Hospital, Cambridge

V3L0A4

RECRUITING

Royal Columbian Hospital, New Westminster

K7L2V7

NOT_YET_RECRUITING

Kingston Health Sciences Centre, Kingston

M5G2C4

NOT_YET_RECRUITING

Toronto General Hospital, Toronto

H1T1C8

NOT_YET_RECRUITING

Montreal Heart Institute, Montreal

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Octapharma

INDUSTRY