Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiopulmonary Bypass

PHASE2CompletedINTERVENTIONAL
Enrollment

425

Participants

Timeline

Start Date

June 26, 2014

Primary Completion Date

January 25, 2018

Study Completion Date

January 25, 2018

Conditions
Cardiac SurgeryCardiopulmonary Bypass
Interventions
BIOLOGICAL

AT-III (Human)

AT-III (Human) is an antithrombin concentrate prepared from pooled human plasma. AT-III (Human) is provided as a freeze-dried preparation for intravenous use. The AT-III (Human) preparation is reconstituted in 10 or 20 mL of sterile water for injection prior to intravenous administration.

OTHER

Placebo

0.9% Sodium Chloride for Injection, United States Pharmacopeia

Trial Locations (41)

11040

North Shore University Hospital, New Hyde Park

15213

UPMC Presbyterian Hospital, Pittsburgh

19104

University of Pennsylvania, Philadelphia

23225

Cardiothoracic Surgical Associates, Richmond

23298

Virginia Commonwealth University Medical Center, Richmond

27710

Duke University Medical Center, Durham

30322

Emory University Hospital, Atlanta

30912

Georgia Regents University, Augusta

32610

University of Florida College of Medicine, Gainesville

33136

Jackson Memorial Hospital at University of Miami, Miami

37205

St. Thomas Health, Nashville

38120

Baptist Memorial Hospital Memphis, Memphis

40536

Kentucky Clinic, Lexington

43210

The Ohio State University Wexner Medical Center, Columbus

43606

ProMedica Toledo Hospital, Toledo

43614

University of Toledo Medical Center, Toledo

44106

University Hospitals Case Medical Center, Cleveland

44304

Summa Health Hospital, Akron

45219

The Lindner Center for Research & Education - The Christ Hospital, Cincinnati

46290

St. Vincent Heart Center of IN, LLC, Indianapolis

46804

Indiana Ohio Heart, Fort Wayne

48073

William Beaumont Hospital, Royal Oak

48910

Sparrow Clinical Research Institute, Lansing

58103

Sanford Health Fargo, Fargo

62794

Memorial Medical Center, Springfield

63131

Missouri Baptist Medical Center, St Louis

64111

Saint Luke's Hospital, Kansas City

68198

University of Nebraska Medical Center, Omaha

68526

CHI Health Nebraska Heart Medical Office, Lincoln

70112

Tulane University Medical, New Orleans

77030

Texas Heart, Houston

77401

Memorial Hermann Memorial City Medical Center, Bellaire

80045

University of Colorado, Aurora

92868

UC Irvine, Orange

94121

VA Medical Center - San Francisco, San Francisco

94305

Stanford University Hospital and Clinics, Stanford

97239

Oregon Health & Science University, Portland

06510

Yale University School of Medicine, New Haven

04102

Maine Medical Center, Portland

02115

Brigham & Women's Hospital, Boston

03766

Dartmouth-Hitchcock Medical Center, Lebanon

Sponsors
All Listed Sponsors
collaborator

Covance

INDUSTRY

collaborator

Clinipace Worldwide

INDUSTRY

lead

Grifols Therapeutics LLC

INDUSTRY