A Study of Fibrocaps™ in Surgical Bleeding

Completed · Phase 3

Conditions studied: Mild or Moderate Surgical Bleeding

In brief

The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis. The investigational products were used in participants with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery, when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical.

Key facts

Study ID

NCT01527357

Run by

Mallinckrodt

People needed

721

Starts

2012-05-21

Expected to finish

2013-06-01

Last updated by the study team

2019-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has signed an institutional review board/independent ethics committee (IRB/IEC)-approved informed consent document
• Is undergoing one of the 4 surgical procedures described
• Is at least 18 years old at time of consent
• If female and of child-bearing potential, has negative pregnancy test during screening and is not breast-feeding
• If able to reproduce, agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits when engaging in heterosexual intercourse
• Has not received blood transfusion between screening and study treatment
• Has mild to moderate surgical bleeding
• Does not have intra-operative complications
• Has not used a topical hemostat containing thrombin prior to study treatment
• Has an approximate bleeding site surface area of less than or equal to 100 cm\^2

You may not qualify if…

• Has known antibodies or hypersensitivity to thrombin or other coagulation factors
• Has history of heparin-induced thrombocytopenia (only for vascular subjects where heparin use is required)
• Has known allergy to gelatin sponge
• Is unwilling to receive blood products
• Has liver enzymes appropriate for the study, considering their disease
• Has appropriate level of platelets per liter (PLT/L) during screening
• Has any clinically-significant coagulation disorder that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the Investigator, or baseline abnormalities during screening that are not explained by current drug treatment (e.g., warfarin, heparin)

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Cardio-Thoracic Surgeons, PC — Birmingham, Alabama, United States
• University of Southern California, Keck School of Medicine — Los Angeles, California, United States
• University of Southern California/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Vascular Interventional Specialists of Orange County — Orange, California, United States
• Lotus Clinical Research, LLC — Pasadena, California, United States
• Boulder Neurological Institute — Boulder, Colorado, United States
• Spine Colorado — Durango, Colorado, United States
• Northwestern University — Chicago, Illinois, United States
• NorthShore University HealthSystem — Skokie, Illinois, United States
• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• Indiana Spine Group — Carmel, Indiana, United States
• Bluegrass Orthopedics — Lexington, Kentucky, United States
• Lahey Clinic Medical Center — Burlington, Massachusetts, United States
• Borgess Research Institute — Kalamazoo, Michigan, United States
• Beaumont Health System — Royal Oak, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• William Muir MD Spine Surgery — Las Vegas, Nevada, United States
• New York-Presbyterian Hospital/Columbia University — New York, New York, United States
• Duke University Hospital Medical Center — Durham, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• The University of Oklahoma - Tulsa — Tulsa, Oklahoma, United States
• Oregon Health & Science University Hospital & Clinics — Portland, Oregon, United States
• University of North Texas Health Sciences Center — Fort Worth, Texas, United States
• Physician's Research Options — Sandy City, Utah, United States

Full record on ClinicalTrials.gov

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