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

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

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.

Study Overview

• Status: Completed
• Conditions: Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
  • Arizona
    • Tucson, Arizona, United States
  • California
    • Fresno, California, United States
    • Orange, California, United States
  • District of Columbia
    • Washington, District of Columbia, United States
  • Florida
    • Jacksonville, Florida, United States
    • Melbourne, Florida, United States
  • Indiana
    • Fort Wayne, Indiana, United States
  • Kentucky
    • Lexington, Kentucky, United States
  • Louisiana
    • Baton Rouge, Louisiana, United States
  • Michigan
    • Saginaw, Michigan, United States
    • Southfield, Michigan, United States
  • New Jersey
    • Hackensack, New Jersey, United States
  • New York
    • Bronx, New York, United States
    • Buffalo, New York, United States
  • Ohio
    • Dayton, Ohio, United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States
  • Texas
    • San Antonio, Texas, United States
  • Utah
    • Salt Lake City, Utah, United States
  • Virginia
    • Charlottesville, Virginia, United States
  • Washington
    • Bellevue, Washington, United States
    • Seattle, Washington, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FS VH S/D 500 s-apr; 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); 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).; Other Names: Biological two-component fibrin sealant
Active Comparator: Manual compression with surgical gauze pads; Dry gauze pads will be positioned to cover the complete study suture line.	Other: Surgical gauze pads; Manual compression with surgical gauze pads

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital Signs: Heart Rate - Preoperative Baseline		Within 14 days prior to date of surgery
Vital Signs: Respiratory Rate - Preoperative Baseline		Within 14 days prior to date of surgery
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
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
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
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: International Normalized Ratio(INR)		Preoperative baseline through postoperative Day 14

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Investigators: Study Director: Isabella Presch, MD, MBA, Baxter Innovations GmbH

Publications and helpful links

General Publications

• Saha SP, Muluk S, Schenk W 3rd, Dennis JW, Ploder B, Grigorian A, Presch I, Goppelt A. A prospective randomized study comparing fibrin sealant to manual compression for the treatment of anastomotic suture-hole bleeding in expanded polytetrafluoroethylene grafts. J Vasc Surg. 2012 Jul;56(1):134-41. doi: 10.1016/j.jvs.2012.01.009. Epub 2012 May 25.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: May 4, 2009
• First Submitted That Met QC Criteria: May 4, 2009
• First Posted (Estimate): May 5, 2009

Study Record Updates

• Last Update Posted (Estimate): November 27, 2012
• Last Update Submitted That Met QC Criteria: October 26, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Vascular Surgery; Arterio-arterial bypasses; Arterio-venous (AV) shunts
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Serine Proteinase Inhibitors; Hemostatics; Coagulants; Trypsin Inhibitors; Fibrin Tissue Adhesive; Thrombin; Aprotinin
• Other Study ID Numbers: 550801