NCT00892957已完成3 期
Clinical Evaluation of Efficacy and Safety of FS VH S/D 500 S-apr for Hemostasis in Subjects Undergoing Vascular Surgery
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 22
- 主要终点
- Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.)
排除标准
- •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)
结局指标
主要结局
Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application.
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
研究点 (22)
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