FS VH S/D 500 S-apr in Vascular Surgery

Study Overview
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Brief Summary
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The purpose of this study was to compare safety and efficacy of FS VH S/D 500 s-apr (FS) versus manual compression in prosthetic expanded polytetrafluoroethylene (ePTFE) graft placement.

Official Title
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Clinical Evaluation of Efficacy and Safety of FS VH S/D 500 S-apr for Hemostasis in Subjects Undergoing Vascular Surgery

Conditions
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Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses

Intervention / Treatment
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* Biological: Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)
* Other: Surgical gauze pads


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preoperative inclusion criteria: Subjects undergoing vascular surgery (ie, conduit placement with an ePTFE graft), including arterio-arterial bypasses, including: axillo-femoral axillo-bifemoral aorto-bifemoral ilio-femoral femoro-femoral ilio-popliteal femoro-popliteal (including below knee) femoro-tibial vessel bypass arterio-venous shunting for dialysis access in the upper or lower extremity Signed informed consent Subject is of childbearing potential, presents with a negative serum or urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study. Subject is willing and able to comply with the requirements of the protocol. Intraoperative inclusion criterion: Suture line bleeding eligible for study treatment is present after surgical hemostasis (ie, suturing). (A definition of eligible suture line bleeding is provided in the study protocol.) Exclusion Criteria: Preoperative exclusion criteria: Other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed) Congenital coagulation disorders Prior kidney transplantation Heparin-induced thrombocytopenia Known hypersensitivity to heparin Known hypersensitivity to aprotinin or other components of the product Known severe congenital or acquired immunodeficiency (eg, HIV infection or long-term treatment with immunosuppressive drugs (eg, organ transplantation patients) Prior radiation therapy to the operating field Severe local inflammation at the operating field Subject is pregnant or lactating at the time of enrollment Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study Subject has previously participated in this study (Protocol No.: 550801), ie, each subject can only be enrolled once. Intraoperative Exclusion Criteria: Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure Intraoperative change in planned surgical procedure, which results in subject no longer meeting preoperative inclusion and/or exclusion criteria, (eg, abandonment of ePTFE graft placement)
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: FS VH S/D 500 s-apr<br>FS VH S/D 500 s-apr will be applied to the study suture line. | Biological: Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)<br>* The actual dose of FS VH S/D 500 s-apr will depend on the length of the suture line and the intensity of bleeding (but shall not exceed 4 mL FS VH S/D 500 s-apr).<br>* Other names: Biological two-component fibrin sealant;|
| Active Comparator: Manual compression with surgical gauze pads<br>Dry gauze pads will be positioned to cover the complete study suture line. | Other: Surgical gauze pads<br>* Manual compression with surgical gauze pads<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application. | Hemostasis at the study suture line must be maintained until closure of the surgical wound. | 4 minutes post start of treatment application | 
| Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding | Investigators were shown videos of bleeding severities to standardize assessments. Moderate bleeding defined as: Either >25% of the suture line bleeds, or ≥5 suture line bleedings were present, if counting of suture line bleedings was possible, or 1 pulsatile suture line bleeding was present. | 4 minutes post start of treatment application | 
| Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding | Investigators were shown videos of bleeding severities to standardize assessments. Severe bleeding defined as: Either >50% of the suture line bleeds, or ≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or >1 pulsatile suture line bleeding was present, or ≥1 spurting suture line bleeding was present. | 4 minutes post start of treatment application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Achieved Hemostasis at 6 Minutes Post Treatment Application | Hemostasis at the study suture line must be maintained until closure of the surgical wound. | 6 minutes post start of treatment application | 
| Percentage of Participants Who Achieved Hemostasis at 10 Minutes Post Treatment Application | Hemostasis at the study suture line must be maintained until closure of the surgical wound. | 10 minutes post start of treatment application | 
| Percentage of Participants With Intraoperative Rebleeding After Hemostasis at Study Suture Line | Intraoperative rebleeding at the study suture line after occurrence of hemostasis. | Intraoperative day 0 | 
| Percentage of Participants With Postoperative Rebleeding | Any rebleeding requiring surgical re-exploration | Postoperative through day 30 ± 5 | 
| Percentage of Participants With Graft Occlusion | Determined clinically and defined as absence of blood flow through the graft. | post-op discharge/day 1, post-op day 14 and day 30 | 
| Percentage of Participants With Infection at the Surgical Site |  | post-op discharge/day 1, post-op day 14 and day 30 | 
| Number of Participants With Infections by Grade | Infections were recorded according to: Grade I: only dermis affected Grade II: infection invades subcutaneous region but not the arterial implant Grade III: the arterial implant is infected | post-op discharge/day 1, post-op day 14 and day 30 | 
| Vital Signs: Systolic and Diastolic Blood Pressure (BP)- Preoperative Baseline |  | Within 14 days prior to date of surgery | 
| Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Percent Change in Systolic and Diastolic Blood Pressure (BP) Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14 | Within 14 days prior to surgery through postoperative day 14 | 
| Vital Signs: Heart Rate - Preoperative Baseline |  | Within 14 days prior to date of surgery | 
| Percent Change in Vital Signs: Heart Rate | Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14 | Within 14 days prior to surgery through postoperative day 14 | 
| Vital Signs: Respiratory Rate - Preoperative Baseline |  | Within 14 days prior to date of surgery | 
| Percent Change in Vital Signs: Respiratory Rate | Percent Change in Heart Rate Measured as: Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14 | Within 14 days prior to surgery through postoperative day 14 | 
| Laboratory Values Over Time: Hemoglobin |  | Preoperative baseline through postoperative Day 14 | 
| Laboratory Values Over Time: Hematocrit |  | Preoperative baseline through postoperative Day 14 | 
| Laboratory Values Over Time: Erythrocytes |  | Preoperative baseline through postoperative Day 14 | 
| Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes |  | Preoperative baseline through postoperative Day 14 | 
| Laboratory Values Over Time: Platelets |  | Preoperative baseline through postoperative Day 14 | 
| Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) |  | Preoperative baseline through postoperative Day 14 | 
| Laboratory Values Over Time: Alanine Aminotransferase (ALT) |  | Preoperative baseline through postoperative Day 14 | 
| Laboratory Values Over Time: Aspartate Aminotransferase (AST) |  | Preoperative baseline through postoperative Day 14 | 
| Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT) |  | Preoperative baseline through postoperative Day 14 | 
| Laboratory Values Over Time: International Normalized Ratio(INR) |  | Preoperative baseline through postoperative Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular Surgery, Arterio-arterial bypasses, Arterio-venous (AV) shunts