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Completed

NCT Number: NCT00892957

FS VH S/D 500 S-apr in 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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

Other names: Biological two-component fibrin sealant

Surgical gauze pads

Other

Manual compression with surgical gauze pads

Primary outcomes

  1. Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application.

    Time frame: 4 minutes post start of treatment application

    Hemostasis at the study suture line must be maintained until closure of the surgical wound.

  2. 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

    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.

  3. 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

    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 outcomes

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

    Time frame: 6 minutes post start of treatment application

    Hemostasis at the study suture line must be maintained until closure of the surgical wound.

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

    Time frame: 10 minutes post start of treatment application

    Hemostasis at the study suture line must be maintained until closure of the surgical wound.

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

    Time frame: Intraoperative day 0

    Intraoperative rebleeding at the study suture line after occurrence of hemostasis.

  4. Percentage of Participants With Postoperative Rebleeding

    Time frame: Postoperative through day 30 ± 5

    Any rebleeding requiring surgical re-exploration

  5. Percentage of Participants With Graft Occlusion

    Time frame: post-op discharge/day 1, post-op day 14 and day 30

    Determined clinically and defined as absence of blood flow through the graft.

  6. Percentage of Participants With Infection at the Surgical Site

    Time frame: post-op discharge/day 1, post-op day 14 and day 30

  7. Number of Participants With Infections by Grade

    Time frame: post-op discharge/day 1, post-op day 14 and day 30

    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

  8. Vital Signs: Systolic and Diastolic Blood Pressure (BP)- Preoperative Baseline

    Time frame: Within 14 days prior to date of surgery

  9. Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure

    Time frame: Within 14 days prior to surgery through postoperative day 14

    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

  10. Vital Signs: Heart Rate - Preoperative Baseline

    Time frame: Within 14 days prior to date of surgery

  11. Percent Change in Vital Signs: Heart Rate

    Time frame: Within 14 days prior to surgery through postoperative day 14

    Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14

  12. Vital Signs: Respiratory Rate - Preoperative Baseline

    Time frame: Within 14 days prior to date of surgery

  13. Percent Change in Vital Signs: Respiratory Rate

    Time frame: Within 14 days prior to surgery through postoperative day 14

    Percent Change in Heart Rate Measured as: Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14

  14. Laboratory Values Over Time: Hemoglobin

    Time frame: Preoperative baseline through postoperative Day 14

  15. Laboratory Values Over Time: Hematocrit

    Time frame: Preoperative baseline through postoperative Day 14

  16. Laboratory Values Over Time: Erythrocytes

    Time frame: Preoperative baseline through postoperative Day 14

  17. Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes

    Time frame: Preoperative baseline through postoperative Day 14

  18. Laboratory Values Over Time: Platelets

    Time frame: Preoperative baseline through postoperative Day 14

  19. Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN)

    Time frame: Preoperative baseline through postoperative Day 14

  20. Laboratory Values Over Time: Alanine Aminotransferase (ALT)

    Time frame: Preoperative baseline through postoperative Day 14

  21. Laboratory Values Over Time: Aspartate Aminotransferase (AST)

    Time frame: Preoperative baseline through postoperative Day 14

  22. Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)

    Time frame: Preoperative baseline through postoperative Day 14

  23. Laboratory Values Over Time: International Normalized Ratio(INR)

    Time frame: Preoperative baseline through postoperative Day 14

Sponsors and collaborators

Lead sponsor

Baxter Healthcare Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 5, 2009
Registry last updated
Nov 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.