- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00576420
Fibrin Sealant Vascular Surgery Study
Clinical Evaluation of Efficacy and Safety of FS VH S/D 500 S-apr for Hemostasis in Subjects Undergoing Vascular Surgery
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States
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Arizona
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Tucson, Arizona, United States
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California
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Long Beach, California, United States
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Florida
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Jacksonville, Florida, United States
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Kentucky
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Lexington, Kentucky, United States
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Louisiana
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Baton Rouge, Louisiana, United States
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Pennsylvania
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Pittsburgh, Pennsylvania, United States
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Utah
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Salt Lake City, Utah, United States
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Virginia
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Charlottesville, Virginia, United States
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Virginia Beach, Virginia, United States
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Washington
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Seattle, Washington, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: FS VH S/D 500 s-apr - 60-Seconds
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) will be applied to the study suture line, 60-second polymerization time
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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.
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Experimental: FS VH S/D 500 s-apr - 120-Seconds
FS VH S/D 500 s-apr will be applied to the study suture line, 120-second polymerization time
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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.
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Active Comparator: Control Group- Manual compression with surgical gauze pads
Treatment of the study-suture line will be manual compression with surgical gauze pads.
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Treatment of the study suture line with manual compression with surgical gauze pads.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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Hemostasis at the study suture line must be maintained. Participants were considered treatment failures if they met any of the following conditions:
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4 minutes post start of treatment application
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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
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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:
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4 minutes post start of treatment application
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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
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Investigators were shown videos of bleeding severities to standardize assessments.
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4 minutes post start of treatment application
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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
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Investigators were shown videos of bleeding severities to standardize assessments. Severe bleeding defined as:
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4 minutes post start of treatment application
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants Achieving Hemostasis at 6 Minutes
Time Frame: 6 minutes post start of treatment application start
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Hemostasis at the study suture line must be maintained until closure of the surgical wound.
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6 minutes post start of treatment application start
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Percentage of Participants Achieving Hemostasis at 10 Minutes
Time Frame: 10 minutes post start of treatment application
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Hemostasis at the study suture line must be maintained until closure of the surgical wound.
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10 minutes post start of treatment application
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Percentage of Participants With Intraoperative Rebleeding After Hemostasis at the Study Suture Line
Time Frame: Intraoperative day 0
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Intraoperative rebleeding at the study suture line after occurrence of hemostasis.
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Intraoperative day 0
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Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line
Time Frame: Postoperative through day 30 ± 5
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Any rebleeding requiring surgical reexploration
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Postoperative through day 30 ± 5
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Percentage of Participants With Any Transfusion Requirement
Time Frame: Intraoperative (day 0) through day 30 ± 5
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Proportion of participants who required transfusions (i.e., red blood cell (RBC) concentrates, fresh frozen plasma (FFP), and platelets)
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Intraoperative (day 0) through day 30 ± 5
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Percentage of Participants With Graft Occlusions
Time Frame: Day 0 (procedure day) through day 30 ± 5
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Determined clinically and defined as absence of blood flow through the graft.
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Day 0 (procedure day) through day 30 ± 5
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Percentage of Participants With Infections at the Surgical Site
Time Frame: Day 0 (procedure day) through day 30 ± 5
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Day 0 (procedure day) through day 30 ± 5
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Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline
Time Frame: Within 14 days prior to date of surgery
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Within 14 days prior to date of surgery
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Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure
Time Frame: Preoperative baseline through postoperative Day 14
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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
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Preoperative baseline through postoperative Day 14
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Vital Signs: Heart Rate - Preoperative Baseline
Time Frame: Within 14 days prior to date of surgery
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Within 14 days prior to date of surgery
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Percent Change in Vital Signs: Heart Rate
Time Frame: Preoperative baseline through postoperative Day 14
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Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14
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Preoperative baseline through postoperative Day 14
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Vital Signs: Respiratory Rate - Preoperative Baseline
Time Frame: Within 14 days prior to date of surgery
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Within 14 days prior to date of surgery
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Percent Change in Vital Signs: Respiratory Rate
Time Frame: Preoperative baseline through postoperative Day 14
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Percent Change in Respiratory Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14
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Preoperative baseline through postoperative Day 14
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Laboratory Values Over Time: Hemoglobin
Time Frame: Preoperative baseline through postoperative Day 14
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Preoperative baseline through postoperative Day 14
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Laboratory Values Over Time: Hematocrit
Time Frame: Preoperative baseline through postoperative Day 14
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Preoperative baseline through postoperative Day 14
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Laboratory Values Over Time: Erythrocytes
Time Frame: Preoperative baseline through postoperative Day 14
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Preoperative baseline through postoperative Day 14
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Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes
Time Frame: Preoperative baseline through postoperative Day 14
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Preoperative baseline through postoperative Day 14
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Laboratory Values Over Time: Platelets
Time Frame: Preoperative baseline through postoperative Day 14
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Preoperative baseline through postoperative Day 14
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Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN)
Time Frame: Preoperative baseline through postoperative Day 14
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Preoperative baseline through postoperative Day 14
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Laboratory Values Over Time: Alanine Aminotransferase (ALT)
Time Frame: Preoperative baseline through postoperative Day 14
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Preoperative baseline through postoperative Day 14
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Laboratory Values Over Time: Aspartate Aminotransferase (AST)
Time Frame: Preoperative baseline through postoperative Day 14
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Preoperative baseline through postoperative Day 14
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Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)
Time Frame: Preoperative baseline through postoperative Day 14
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Preoperative baseline through postoperative Day 14
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Laboratory Values Over Time: International Normalized Ratio (INR)
Time Frame: Preoperative baseline through postoperative Day 14
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Preoperative baseline through postoperative Day 14
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 550602
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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