The Severe Soft Tissue Bleeding Study

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling challenging severe soft tissue bleeding during abdominal, pelvic, retroperitoneal, and (non-cardiac) thoracic surgery.

Official Title
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A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Severe Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic Surgery

Conditions
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Soft Tissue Bleeding

Intervention / Treatment
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* Biological: Fibrin Pad
* Procedure: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects >= 18 years of age, requiring elective, open, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures; Presence of an appropriate severe bleeding soft tissue Target Bleeding Site (TBS) as identified intra-operatively by the surgeon; Subjects must be willing to participate in the study, and provide written informed consent. Exclusion Criteria: Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure; Bleeding site is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of the FP to blood flow and pressure during healing and absorption of the product; Subject with TBS within an actively infected field; Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine; Subjects with known intolerance to blood products or to one of the components of the study product; Subjects unwilling to receive blood products; Subjects with known immunodeficiency diseases (including known HIV); Subjects who are known, current alcohol and / or drug abusers; Subjects who have participated in another investigational drug or device research study within 30 days of enrollment; Female subjects who are pregnant or nursing.

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: Fibrin Pad<br> | Biological: Fibrin Pad<br>* Fibrin Pad is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).<br>|
| Active Comparator: Standard of Care<br> | Procedure: Standard of Care<br>* Standard of Care is a composite of techniques/methods typically used by the surgeon to control severe bleeding.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving hemostasis at the Target Bleeding Site. Hemostasis is defined as no detectable bleeding at the TBS. |  | Intra-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving hemostatic success at 10 minutes following randomization |  | Intra-operative | 
| Absolute time to hemostasis |  | Intra-operative | 
| Proportion of subjects requiring re-treatment at the TBS prior to wound closure |  | Intra-operative | 
| Incidence of treatment failures |  | Intra-operative | 
| Incidence of adverse events that are potentially related to bleeding at the TBS |  | Intra-operative through 60 days | 
| Incidence of adverse events that are potentially related to thrombotic events; |  | Intra-operative through 60 days | 
| Incidence of adverse events |  | Intra-operative through 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemostasis