Clinical Evaluation of Efficacy and Safety of FS VH S/D 500 S-apr for Hemostasis in Subjects Undergoing Vascular Surgery
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses
- Sponsor
- Baxter Healthcare Corporation
- Enrollment
- 176
- Primary Endpoint
- Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
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.
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.
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
- Percentage of Participants Who Achieved Hemostasis at 6 Minutes Post Treatment Application(6 minutes post start of treatment application)
- Percentage of Participants Who Achieved Hemostasis at 10 Minutes Post Treatment Application(10 minutes post start of treatment application)
- Percentage of Participants With Intraoperative Rebleeding After Hemostasis at Study Suture Line(Intraoperative day 0)
- Percentage of Participants With Postoperative Rebleeding(Postoperative through day 30 ± 5)
- Percentage of Participants With Graft Occlusion(post-op discharge/day 1, post-op day 14 and day 30)
- Percentage of Participants With Infection at the Surgical Site(post-op discharge/day 1, post-op day 14 and day 30)
- Number of Participants With Infections by Grade(post-op discharge/day 1, post-op day 14 and day 30)
- Vital Signs: Systolic and Diastolic Blood Pressure (BP)- Preoperative Baseline(Within 14 days prior to date of surgery)
- Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure(Within 14 days prior to surgery 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(Within 14 days prior to surgery through postoperative day 14)
- Vital Signs: Respiratory Rate - Preoperative Baseline(Within 14 days prior to date of surgery)
- Percent Change in Vital Signs: Respiratory Rate(Within 14 days prior to surgery 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)