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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00892957
First received: May 4, 2009
Last updated: October 26, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Efficacy and Safety of FS VH S/D 500 S-apr for Hemostasis in Subjects Undergoing Vascular Surgery

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application. [ Time Frame: 4 minutes post start of treatment application ] [ Designated as safety issue: No ]
    Hemostasis at the study suture line must be maintained until closure of the surgical wound.

  • Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding [ Time Frame: 4 minutes post start of treatment application ] [ Designated as safety issue: No ]

    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.

  • Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding [ Time Frame: 4 minutes post start of treatment application ] [ Designated as safety issue: No ]

    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.


Secondary Outcome Measures:
  • Percentage of Participants Who Achieved Hemostasis at 6 Minutes Post Treatment Application [ Time Frame: 6 minutes post start of treatment application ] [ Designated as safety issue: No ]
    Hemostasis at the study suture line must be maintained until closure of the surgical wound.

  • Percentage of Participants Who Achieved Hemostasis at 10 Minutes Post Treatment Application [ Time Frame: 10 minutes post start of treatment application ] [ Designated as safety issue: No ]
    Hemostasis at the study suture line must be maintained until closure of the surgical wound.

  • Percentage of Participants With Intraoperative Rebleeding After Hemostasis at Study Suture Line [ Time Frame: Intraoperative day 0 ] [ Designated as safety issue: No ]
    Intraoperative rebleeding at the study suture line after occurrence of hemostasis.

  • Percentage of Participants With Postoperative Rebleeding [ Time Frame: Postoperative through day 30 ± 5 ] [ Designated as safety issue: No ]
    Any rebleeding requiring surgical re-exploration

  • Percentage of Participants With Graft Occlusion [ Time Frame: post-op discharge/day 1, post-op day 14 and day 30 ] [ Designated as safety issue: Yes ]
    Determined clinically and defined as absence of blood flow through the graft.

  • Percentage of Participants With Infection at the Surgical Site [ Time Frame: post-op discharge/day 1, post-op day 14 and day 30 ] [ Designated as safety issue: Yes ]
  • Number of Participants With Infections by Grade [ Time Frame: post-op discharge/day 1, post-op day 14 and day 30 ] [ Designated as safety issue: Yes ]

    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

  • Vital Signs: Systolic and Diastolic Blood Pressure (BP)- Preoperative Baseline [ Time Frame: Within 14 days prior to date of surgery ] [ Designated as safety issue: Yes ]
  • Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure [ Time Frame: Within 14 days prior to surgery through postoperative day 14 ] [ Designated as safety issue: Yes ]
    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

  • Vital Signs: Heart Rate - Preoperative Baseline [ Time Frame: Within 14 days prior to date of surgery ] [ Designated as safety issue: Yes ]
  • Percent Change in Vital Signs: Heart Rate [ Time Frame: Within 14 days prior to surgery through postoperative day 14 ] [ Designated as safety issue: Yes ]
    Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14

  • Vital Signs: Respiratory Rate - Preoperative Baseline [ Time Frame: Within 14 days prior to date of surgery ] [ Designated as safety issue: Yes ]
  • Percent Change in Vital Signs: Respiratory Rate [ Time Frame: Within 14 days prior to surgery through postoperative day 14 ] [ Designated as safety issue: Yes ]
    Percent Change in Heart Rate Measured as: Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14

  • Laboratory Values Over Time: Hemoglobin [ Time Frame: Preoperative baseline through postoperative Day 14 ] [ Designated as safety issue: Yes ]
  • Laboratory Values Over Time: Hematocrit [ Time Frame: Preoperative baseline through postoperative Day 14 ] [ Designated as safety issue: Yes ]
  • Laboratory Values Over Time: Erythrocytes [ Time Frame: Preoperative baseline through postoperative Day 14 ] [ Designated as safety issue: Yes ]
  • Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes [ Time Frame: Preoperative baseline through postoperative Day 14 ] [ Designated as safety issue: Yes ]
  • Laboratory Values Over Time: Platelets [ Time Frame: Preoperative baseline through postoperative Day 14 ] [ Designated as safety issue: Yes ]
  • Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) [ Time Frame: Preoperative baseline through postoperative Day 14 ] [ Designated as safety issue: Yes ]
  • Laboratory Values Over Time: Alanine Aminotransferase (ALT) [ Time Frame: Preoperative baseline through postoperative Day 14 ] [ Designated as safety issue: Yes ]
  • Laboratory Values Over Time: Aspartate Aminotransferase (AST) [ Time Frame: Preoperative baseline through postoperative Day 14 ] [ Designated as safety issue: Yes ]
  • Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT) [ Time Frame: Preoperative baseline through postoperative Day 14 ] [ Designated as safety issue: Yes ]
  • Laboratory Values Over Time: International Normalized Ratio(INR) [ Time Frame: Preoperative baseline through postoperative Day 14 ] [ Designated as safety issue: Yes ]

Enrollment: 176
Study Start Date: July 2009
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892957

  Show 22 Study Locations
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Isabella Presch, MD, MBA Baxter Innovations GmbH
  More Information

Publications:
Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00892957     History of Changes
Other Study ID Numbers: 550801
Study First Received: May 4, 2009
Results First Received: September 13, 2012
Last Updated: October 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Baxter Healthcare Corporation:
Vascular Surgery
Arterio-arterial bypasses
Arterio-venous (AV) shunts

Additional relevant MeSH terms:
Aprotinin
Fibrin Tissue Adhesive
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014