Clinical Evaluation of Efficacy and Safety of FS VH S/D 500 S-apr for Hemostasis in Subjects Undergoing Vascular Surgery
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts)
- Sponsor
- Baxter Healthcare Corporation
- Enrollment
- 101
- Primary Endpoint
- Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
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.
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.
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. 1. 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. 2. 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.
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
- Vital Signs: Respiratory Rate - Preoperative Baseline(Within 14 days prior to date of surgery)
- Percentage of Participants Achieving Hemostasis at 6 Minutes(6 minutes post start of treatment application start)
- Percentage of Participants Achieving Hemostasis at 10 Minutes(10 minutes post start of treatment application)
- Percentage of Participants With Intraoperative Rebleeding After Hemostasis at the Study Suture Line(Intraoperative day 0)
- Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line(Postoperative through day 30 ± 5)
- Percentage of Participants With Any Transfusion Requirement(Intraoperative (day 0) through day 30 ± 5)
- Percentage of Participants With Graft Occlusions(Day 0 (procedure day) through day 30 ± 5)
- Percentage of Participants With Infections at the Surgical Site(Day 0 (procedure day) through day 30 ± 5)
- Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline(Within 14 days prior to date of surgery)
- Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure(Preoperative baseline through postoperative Day 14)
- Vital Signs: Heart Rate - Preoperative Baseline(Within 14 days prior to date of surgery)
- Percent Change in Vital Signs: Heart Rate(Preoperative baseline through postoperative Day 14)
- Percent Change in Vital Signs: Respiratory Rate(Preoperative baseline through postoperative Day 14)
- Laboratory Values Over Time: Hemoglobin(Preoperative baseline through postoperative Day 14)
- Laboratory Values Over Time: Hematocrit(Preoperative baseline through postoperative Day 14)
- Laboratory Values Over Time: Erythrocytes(Preoperative baseline through postoperative Day 14)
- Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes(Preoperative baseline through postoperative Day 14)
- Laboratory Values Over Time: Platelets(Preoperative baseline through postoperative Day 14)
- Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN)(Preoperative baseline through postoperative Day 14)
- Laboratory Values Over Time: Alanine Aminotransferase (ALT)(Preoperative baseline through postoperative Day 14)
- Laboratory Values Over Time: Aspartate Aminotransferase (AST)(Preoperative baseline through postoperative Day 14)
- Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)(Preoperative baseline through postoperative Day 14)
- Laboratory Values Over Time: International Normalized Ratio (INR)(Preoperative baseline through postoperative Day 14)