A Study of Fibrocaps™ in Surgical Bleeding

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis

Conditions
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Mild or Moderate Surgical Bleeding

Intervention / Treatment
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* Biological: Fibrocaps
* Biological: Gelatin sponge


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fibrocaps + Gelatin Sponge<br>Single application of Fibrocaps plus gelatin sponge. | Biological: Fibrocaps<br>* Human fibrinogen and thrombin powder, for topical administration.<br>* Other names: Fibrin sealant;Biological: Gelatin sponge<br>* Absorbable gelatin sponge for topical administration.<br>* Other names: Spongostan;|
| Active Comparator: Gelatin Sponge<br>Single application of gelatin sponge alone. | Biological: Gelatin sponge<br>* Absorbable gelatin sponge for topical administration.<br>* Other names: Spongostan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery | 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. | Within 5 minutes | 
| Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery | 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. | Within 5 minutes | 
| Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection | 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. | Within 5 minutes | 
| Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection | 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. | Within 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restricted Mean TTH | Restricted mean TTH over 5 minutes is computed using Irwin's estimator, based on data collected by surgery type and treatment. | Within 5 minutes | 
| Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | 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. | Within 29 days | 
| Number of Participants Who Require Alternative Hemostatic Agents 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. | At 5 minutes | 
| Number of Participants Who Required Red Blood Cells | 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. | Within 29 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemostasis, fibrin sealant, thrombin, fibrinogen