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Completed

NCT Number: NCT00576420

Fibrin Sealant Vascular Surgery Study

The purpose of this study is to evaluate the efficacy and safety of Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) for hemostasis in participants receiving prosthetic expanded polytetrafluoroethylene (ePTFE) conduits as compared to a control group treated by manual compression with surgical gauze pads.

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Key information

Conditions

Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts)

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

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

  • Male or female of all ages
  • Subject undergoing peripheral vascular surgery, ie, conduit placement with an ePTFE graft such as arterio-arterial bypasses [including: axillo-femoral, ilio-femoral, femoro-femoral, ilio-popliteal, femoro-popliteal (including below knee), femoro-tibial vessel bypass], or arteriovenous dialysis access shunt in the upper or lower extremity.
  • Signed informed consent

Intraoperative inclusion criterion:

  • Suture line bleeding eligible for study treatment is present after surgical hemostasis (i.e., suturing).

Suture line bleeding eligible for study treatment is defined as: any suture line bleeding that would prevent immediate closure of the wound and require treatment of the bleeding first, and on a scale of mild, moderate, and severe, the suture line bleeding is assessed as moderate or severe. (Moderate is defined as: either more than 25% of the suture line bleeds, or at least 5 suture line bleedings are present, if counting of suture line bleedings is possible, or one pulsatile suture line bleeding is present. Severe is defined as: either more than 50% of the suture line bleeds, or at least 10 suture line bleedings present, if counting of suture line bleedings is possible, or more than one pulsatile suture line bleedings are present, or at least one spurting suture line bleeding is present.)

Note: Bleedings that can be treated with additional sutures are not appropriate for the study. Such anastomoses should receive additional sutures, be re-categorized, and if they still comply with the inclusion criteria, be randomized.

Exclusion criteria

  • Subjects concurrently participating in another clinical study treatment with another investigational drug or device within the last 30 days
  • Other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed)
  • Arterio-arterial bypasses with more than 2 anastomoses (e.g., aorto-bifemoral, axillo-bifemoral etc.)
  • Pregnant or lactating women
  • Congenital coagulation disorders
  • Prior kidney transplantation
  • Heparin-induced thrombocytopenia
  • Known prior exposure to aprotinin within the last 12 months
  • Known hypersensitivity to aprotinin or other components of the product
  • Known severe congenital or acquired immunodeficiency (e.g., HIV infection or long term treatment with immunosuppressive drugs)
  • Prior radiation therapy to the operating field
  • Severe local inflammation at the operating field.

Intraoperative exclusion criterion:

  • 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, (e.g. abandonment of ePTFE graft placement).

Treatment and study plan

FS VH S/D 500 s-apr, 60-seconds polymerization time

Biological

FS VH S/D 500 s-apr (FS) is applied to the study suture line. The actual dose of FS VH S/D 500 s-apr depends on the length of the suture line and the intensity of bleeding and is to be decided by the surgeon, but the maximum dose per suture line shall not exceed 4 mL FS VH S/D 500 s apr. After application of FS VH S/D 500 s-apr to the study suture line is completed, the surgeon will wait for 1 minute to allow polymerization of FS VH S/D 500 s-apr.

FS VH S/D 500 s-apr, 120-seconds polymerization time

Biological

Treatment will be identical to the FS VH S/D 500 s-apr Group, 60 seconds polymerization time, except that the surgeons will wait 2 minutes to allow polymerization and will then open the cross clamps.

Manual compression with surgical gauze pads

Procedure

Treatment of the study suture line with manual compression with surgical gauze pads.

Primary outcomes

  1. Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line.

    Time frame: 4 minutes post start of treatment application

    Hemostasis at the study suture line must be maintained.

    Participants were considered treatment failures if they met any of the following conditions:

    • Did not achieve hemostasis at 4 minutes
    • Required additional hemostatic treatment during the first 4 minutes of the observation period
    • Experienced rebleeding after the first 4 minutes of the observation period.

  2. 90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line

    Time frame: 4 minutes post start of treatment application

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

    Participants were considered treatment failures if they met any of the following conditions:

    • Did not achieve hemostasis at 4 minutes
    • Required additional hemostatic treatment other than study treatment during the first 4 minutes of the observation period
    • Experienced rebleeding after the first 4 minutes of the observation period.

  3. 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.
    • 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. 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 Achieving Hemostasis at 6 Minutes

    Time frame: 6 minutes post start of treatment application start

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

  2. Percentage of Participants Achieving Hemostasis at 10 Minutes

    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 the 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 After Hemostasis at the Study Suture Line

    Time frame: Postoperative through day 30 ± 5

    Any rebleeding requiring surgical reexploration

  5. Percentage of Participants With Any Transfusion Requirement

    Time frame: Intraoperative (day 0) through day 30 ± 5

    Proportion of participants who required transfusions (i.e., red blood cell (RBC) concentrates, fresh frozen plasma (FFP), and platelets)

  6. Percentage of Participants With Graft Occlusions

    Time frame: Day 0 (procedure day) through day 30 ± 5

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

  7. Percentage of Participants With Infections at the Surgical Site

    Time frame: Day 0 (procedure day) through day 30 ± 5

  8. Vital Signs: Systolic and Diastolic Blood Pressure - 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: Preoperative baseline 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: Preoperative baseline 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: Preoperative baseline through postoperative Day 14

    Percent Change in Respiratory Rate Measured as: Preoperative Baseline - Intraoperative Day 0; 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
2007
Primary completion
2008
Study completion
2008
First posted
Dec 19, 2007
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.