A Study of Fibrocaps™ in Surgical Bleeding

PHASE3CompletedINTERVENTIONAL
Enrollment

721

Participants

Timeline

Start Date

May 21, 2012

Primary Completion Date

April 24, 2013

Study Completion Date

June 1, 2013

Conditions
Mild or Moderate Surgical Bleeding
Interventions
BIOLOGICAL

Fibrocaps

Human fibrinogen and thrombin powder, for topical administration.

BIOLOGICAL

Gelatin sponge

Absorbable gelatin sponge for topical administration.

Trial Locations (48)

0

Rijnstate Arnhem, Velp

1120

Militair Hospitaal Koningin Astrid, Brussells

3000

Universitair Ziekenhuis Leuven, Abdominale Heelkunde, Leuven

4800

Amphia Hospital, Breda

9000

Universitair Ziekenhuis Gent, Gasto-Intestinale Heelkunde, Ghent

27710

Duke University Hospital Medical Center, Durham

35233

University of Alabama at Birmingham, Birmingham

35242

Cardio-Thoracic Surgeons, PC, Birmingham

40509

Bluegrass Orthopedics, Lexington

44195

Cleveland Clinic Foundation, Cleveland

46032

Indiana Spine Group, Carmel

48073

Beaumont Health System, Royal Oak

49048

Borgess Research Institute, Kalamazoo

60077

NorthShore University HealthSystem, Skokie

60611

Northwestern University, Chicago

62702

Southern Illinois University School of Medicine, Springfield

63110

Washington University School of Medicine, St Louis

74135

The University of Oklahoma - Tulsa, Tulsa

76107

University of North Texas Health Sciences Center, Fort Worth

80304

Boulder Neurological Institute, Boulder

81303

Spine Colorado, Durango

84070

Physician's Research Options, Sandy City

89144

William Muir MD Spine Surgery, Las Vegas

90033

University of Southern California, Keck School of Medicine, Los Angeles

University of Southern California/Norris Comprehensive Cancer Center, Los Angeles

91105

Lotus Clinical Research, LLC, Pasadena

92868

Vascular Interventional Specialists of Orange County, Orange

98004

Overlake Hospital Medical Center, Bellevue

98101

Virginia Mason Medical Center, Seattle

98405

Multicare Neuroscience Center of Washington, Tacoma

99208

Northwest Orthopaedic Specialists, P.S., Spokane

100032

New York-Presbyterian Hospital/Columbia University, New York

01805

Lahey Clinic Medical Center, Burlington

97239-3098

Oregon Health & Science University Hospital & Clinics, Portland

B-1040

Clinique du Parc Leopold, Service de Neurochirurgie, Brussels

B-1070

Hopital Erasme, Service de Neurochirurgie, Brussels

7513 ER

Medisch Spectrum Twente, Enschede

9700 RB

University Medical Centre Groningen, Groningen

2300 RC

Leiden University Medical Center, Leiden

6525 GA

Radboud University Medical Center, Nijmegen

3075 EA

Erasmus Medical Center, Rotterdam

B15 2WB

Queen Elizabeth Hospital Birmingham, Birmingham

CB2 0QQ

Addenbrookes Hospital Vascular Department, Cambridge

DN2 5LT

Doncaster Royal Infirmary, Doncaster

HU3 2JZ

Hull Royal Infirmary, Hull

LS1 3EX

Leeds General Infirmary, Leeds

SE5 9RS

King's College Hospital, London

NE7 7DN

Freeman Hospital, Newcastle upon Tyne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mallinckrodt

INDUSTRY

NCT01527357 - A Study of Fibrocaps™ in Surgical Bleeding | Biotech Hunter | Biotech Hunter