A Study of Fibrocaps in Liver Surgery in the Netherlands

Study Overview
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Brief Summary
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A multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in subjects undergoing open liver resection surgery. The study will enroll 42 eligible subjects and be conducted at 4 sites in the Netherlands.

Detailed Description
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This will be a multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in 60 subjects undergoing hepatic resection. Subjects will be randomized in a 2:1 ratio to Fibrocaps + Gelfoam or Gelfoam on the day of surgery. The Fibrospray device will be used to apply Fibrocaps to the Target Bleeding Site. All investigators using the Fibrospray device will be trained on the correct and safe set-up and use of Fibrocaps and the Fibrospray device prior to participating in this clinical trial.

Official Title
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A Phase 2, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety and Study of Topical Fibrocaps™ and Gelatin Sponge in Surgical Hemostasis in the Netherlands

Conditions
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Postoperative Hemorrhage

Intervention / Treatment
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* Biological: Fibrocaps (fibrin sealant)
* Device: Gelatin sponge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ≥ 18 years of age Subjects who are able and willing to provide written and signed informed consent Willing to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits Has a life expectancy of at least one year Presence of mild or moderate bleeding/oozing and control by conventional surgical techniques including but not limited to suture, ligature, and cautery is ineffective or impractical Exclusion Criteria: Pregnant or lactating women Has a known intolerance to blood products or to Fibrocaps components Unwilling to receive human blood products Subject has a known allergy to porcine gelatin Has a mental or physical condition that would, in the opinion of the Investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol Currently participating or has participated in another clinical study involving another investigational agent within 4 weeks of the planned date of surgery, or is planning participation in another clinical trial during the 4 weeks after surgery 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 Platelets(PLT) < 100 x109 PLT/L during screening Activated Partial Thromboplastin Time (aPTT) > 100 seconds during screening International Normalized Ratio (INR) > 2.5 during screening

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>Topical Fibrocaps powder followed by application of gelatin sponge | Biological: Fibrocaps (fibrin sealant)<br>* human thrombin and fibrinogen topical powder<br>* Other names: Fibrin Sealant;Device: Gelatin sponge<br>* absorbable gelatin sponge for topical use<br>* Other names: Spongostan;|
| Active Comparator: Gelatin Sponge<br>approved device for surgical bleeding | Device: Gelatin sponge<br>* absorbable gelatin sponge for topical use<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 | Time from application of treatment to cessation of bleeding | 0-10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Number of participants with Adverse events and clinically significant changes/findings on labs and physical examination as well as incidence of re-operation for bleeding at the target bleeding site (TBS) | 28 days | 
| Incidence of Hemostasis at 5 Minutes | Number of subjects in each group that achieved hemostasis at pre-specified times after treatment | 5 minutes | 
| Number of Subjects Achieving Hemostasis at 3 Minutes |  | 3 minutes | 
| Number of Patients Achieving Hemostasis at 10 Minutes |  | 10 minutes |