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

NCT00892957 | Completed Phase 3 Results

• 1 other identifier: 550801
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 22

Brief Summary

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.

Conditions

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

Keywords

Vascular Surgery; Arterio-arterial bypasses; Arterio-venous (AV) shunts

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (23)

• Percentage of Participants Who Achieved Hemostasis at 6 Minutes Post Treatment Application

  6 minutes post start of treatment application

• Percentage of Participants Who Achieved Hemostasis at 10 Minutes Post Treatment Application

  10 minutes post start of treatment application

• Percentage of Participants With Intraoperative Rebleeding After Hemostasis at Study Suture Line

  Intraoperative day 0

• Percentage of Participants With Postoperative Rebleeding

  Postoperative through day 30 ± 5

• Percentage of Participants With Graft Occlusion

  post-op discharge/day 1, post-op day 14 and day 30

Study Arms (2)

FS VH S/D 500 s-apr

EXPERIMENTAL

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)

Manual compression with surgical gauze pads

ACTIVE COMPARATOR

Dry gauze pads will be positioned to cover the complete study suture line.

Other: Surgical gauze pads

Interventions

Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) BIOLOGICAL

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).

Also known as: Biological two-component fibrin sealant

FS VH S/D 500 s-apr

Surgical gauze pads OTHER

Manual compression with surgical gauze pads

Manual compression with surgical gauze pads

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.)

You may not qualify if:

• 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.
• Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (22)

Unknown Facility

Birmingham, Alabama, United States

Location

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Tucson, Arizona, United States

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Fresno, California, United States

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Orange, California, United States

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Washington D.C., District of Columbia, United States

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Jacksonville, Florida, United States

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Melbourne, Florida, United States

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Fort Wayne, Indiana, United States

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Lexington, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Saginaw, Michigan, United States

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Southfield, Michigan, United States

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Hackensack, New Jersey, United States

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Buffalo, New York, United States

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The Bronx, New York, United States

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Dayton, Ohio, United States

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Pittsburgh, Pennsylvania, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Charlottesville, Virginia, United States

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Bellevue, Washington, United States

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Seattle, Washington, United States

Location

Related Publications (1)

• 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.

  PMID: 22633423 BACKGROUND

MeSH Terms

Interventions

Fibrin Tissue Adhesive; Solvents; Thrombin; Low Density Lipoprotein Receptor-Related Protein-1

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Specialty Uses of Chemicals; Chemical Actions and Uses; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Blood Coagulation Factors; Biological Factors; LDL-Receptor Related Proteins; Receptors, LDL; Receptors, Lipoprotein; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Edith Hantak, Dir, Global Therapeutic Area, BioSurgery
• Organization: BAXTER INNOVATIONS GmbH

edith_hantak@baxter.com

Study Officials

• Isabella Presch, MD, MBA

  Baxter Innovations GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2009
• First Posted: May 5, 2009
• Study Start: July 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 27, 2012
• Results First Posted: November 27, 2012

Record last verified: 2012-10

Locations

US (22)