The Bioseal Vascular Study

Study Overview
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Brief Summary
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To evaluate the clinical utility of Bioseal as an adjunct to control bleeding during elective vascular surgery.

Official Title
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A Prospective, Randomized, Controlled Phase IV Study to Compare Bioseal Versus Manual Compression as an Adjunct to Hemostasis in the Patients Undergoing Elective Vascular Surgery

Conditions
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Cardiovascular Bleeding, Vascular Bleeding, Hemorrhage

Intervention / Treatment
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* Biological: Bioseal Fibrin Sealant
* Other: Manual Compression


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects between 18 and 75 years of age; Undergoing elective vascular surgical procedures and with the presence of an appropriate Target Bleeding Site (TBS) requiring an adjunct to achieve hemostasis as identified intra-operatively by the surgeon ; Able and willing to comply with procedures required by protocol; Signed and dated written informed consent prior to any study related procedures. Exclusion Criteria: Subjects with any intra-operative findings that may preclude conducting of the study procedures; Intended use of Fibrin Sealants (including autologous Fibrin Sealants) other than Bioseal on the TBS; Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products; Subjects with known allergies to or previously used porcine derived products; Female subjects who are known breastfeeding or pregnant or intend to become pregnant during the clinical study period. The subject, in the opinion of the investigator, would not be suitable for participation in the study. Subjects who participated in another trial within 30 days prior to the planned start of treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Bioseal Fibrin Sealant<br>A porcine-derived fibrin sealant consisting of thrombin and fibrinogen | Biological: Bioseal Fibrin Sealant<br> <br> |
| Other: Manual compression<br>Manual compresssion (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants. | Other: Manual Compression<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application. | Percentage of participants with Hemostasis at the TBS at 10 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding. | Intra-operative, 10 minutes following randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostasis at the Target Bleeding Site (TBS) at 3 and 6 Minutes Following the Completion of Treatment Application | Percentage of participants with Hemostasis at the TBS at 3 and 6 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding. | Intra-operative, 3 and 6 minutes following randomization | 
| Number of Participants Requiring Alternative Treatment Due to Treatment Failure* | Alternative treatments include the use of additional hemostatic methods, including collagen, manual compression, oxidized regenerated cellulose and suture. Manual compression (MC) may be applied after the initial 10 minute observation period as an alternative treatment due to treatment failure in either group. For participants with a treatment failure in MC group, the addition treatment of MC is applied after the initial 10 minute observation period. | Intra-operative, 10 minutes following randomization | 
| Percentage of Participants With Potential Bleeding-related Adverse Events | Percentage of participants with potential bleeding-related adverse events by study group | 30-days follow-up |