A Study of Fibrocaps™ in Surgical Bleeding

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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)

Primary Outcome Measures

Name	Time	Method
Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery	Within 5 minutes	The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.
Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection	Within 5 minutes	The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.
Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery	Within 5 minutes	The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.
Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection	Within 5 minutes	The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Required Red Blood Cells	Within 29 days	Red blood cells are defined as including World Health Organization (WHO) DRUG terms of "Blood cells, packed human", "Blood, whole", "Red blood cells", "Red blood cells, concentrated" and "Red blood cells, leucocyte depleted".
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)	Within 29 days	An adverse event (AE) is any untoward medical occurrence (including clinically significant changes in laboratory values or other clinical tests) experienced by a participant administered a pharmaceutical product regardless of causal relationship with the treatment. A TEAE is any adverse event reported on the case report form that occurs after start of treatment or any adverse event with a missing start date.
Restricted Mean TTH	Within 5 minutes	Restricted mean TTH over 5 minutes is computed using Irwin's estimator, based on data collected by surgery type and treatment.
Number of Participants Who Require Alternative Hemostatic Agents at 5 Minutes	At 5 minutes	If hemostasis is not achieved within 5 minutes, the treatment is considered to have failed, and the surgeon is to implement additional hemostatic measures.

Locations (48): 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
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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States