A Prospective, Single-blind, Randomized, Phase II/III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Peripheral Vascular Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 239
- 试验地点
- 38
- 主要终点
- The Primary Efficacy Endpoint is Time to Hemostasis.
研究概览
简要总结
The purpose of this study is to evaluate the safety and hemostasis effectiveness of human plasma-derived fibrin sealant Grifols (FS Grifols) in peripheral vascular surgery.
详细描述
The trial consisted of 2 parts: a Preliminary Part (I) and a Primary Part (II). All subjects enrolled in Preliminary Part (I) were treated with FS Grifols. Subjects in Primary Part (II) were randomly allocated in a 2:1 ratio to treatment with FS Grifols or manual compression. The objectives of the study were to evaluate the hemostasis effectiveness of FS Grifols in peripheral vascular surgery and to assess clinical safety, viral safety, and immunogenicity.
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
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are male or female
- •Must be at least 3 years of age with no upper age limit (must be at least 18 years of age in Spain and United Kingdom)
- •Require an elective (non-emergency), open (non-laparoscopic; non-endovascular) peripheral vascular surgical procedure
- •Have hemoglobin ≥ 9.0 g/dL
- •Have platelet count > 70 x 10^3/mm^3
- •Required one peripheral vascular procedure involving either an arterial patch angioplasty or an arterial anastomosis utilizing polytetrafluoroethylene or Dacron grafts, according to the Investigator's (the surgeon's) selection:
- •Carotid endarterectomy requiring patch angioplasty
- •Carotid-subclavian bypass grafting
- •Axillo-femoral bypass grafting
- •Abdominal aortic aneurysm resection and graft replacement
- •Aorto-mesenteric bypass grafting
- •Aorto-celiac bypass grafting
- •Aorto-uni-iliac bypass grafting
- •Aorto-bi-iliac bypass grafting
- •Aorto-uni-femoral bypass grafting
- •Aorto-bi-femoral bypass grafting
- •Iliac aneurysm resection and graft replacement
- •Femoral aneurysm resection and graft replacement
- •Femoral-femoral bypass grafting
- •Femoral-popliteal bypass grafting
- •Renal arterial revascularization (bypass grafting)
- •Renal arterial revascularization (endarterectomy with patch angioplasty)
- •Popliteal artery revascularization (bypass grafting)
- •Popliteal artery revascularization (endarterectomy with patch angioplasty)
- •Femoral endarterectomy with patch angioplasty
- •Ilio-femoral bypass grafting
- •Intra-operative inclusion criterion:
- •A Target bleeding site (TBS)can be identified according to the Investigator's judgment, and the TBS has a mild or moderate arterial bleeding according to the Investigator's judgment
排除标准
- •Weighed < 20 kg
- •Have a pre-operative (at Baseline Assessments) international normalized ratio ≥ 2.0
- •Have a pre-operative (at Baseline Assessments) activated partial thromboplastin time ratio ≥ 1.5
- •Have a pre-operative (at Baseline Assessments) serum creatinine > 2 times the upper limit of the normal range
- •Were undergoing a re-operative procedure on same arterial patch angioplasty or arterial anastomosis
- •Have an infection in the anatomical surgical area
- •Have a history of severe (e.g., anaphylactic) reactions to blood or any blood derived product
- •Unwilling to receive blood products
- •Have positive bleeding history
- •Female who was pregnant or nursing
- •Are known to abuse alcohol, opiates, psychotropic agents or other chemicals or drugs, or have done so within 12 months to the screening visit.
- •Are currently participating in another investigational drug or device clinical study, or have participated within 3 months to the screening visit.
- •Were previously included in this clinical trial (protocol number IG402)
结局指标
主要结局
The Primary Efficacy Endpoint is Time to Hemostasis.
时间窗: The start of treatment application at the target bleeding site (TBS) to the achievement of hemostasis at that site or to the end of the 10-minute observational period when the hemostasis has not yet been achieved.
The primary efficacy endpoint of the study is time to hemostasis (TTH), measured in minutes from the start of treatment application (TStart) at the TBS to the achievement of hemostasis at that site or to the end of the 10-minute observational period if hemostasis has not yet been achieved.
次要结局
- Proportions of Subjects Achieving Hemostasis(10 minutes from the start of treatment application at the target bleeding site)
- Prevalence of Treatment Failures(10 minutes from the start of treatment application at the target bleeding site)