A Prospective, Single-blind, Randomized, Phase 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
- 3 期
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 38
- 主要终点
- Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start
研究概览
简要总结
The purpose of this study is to demonstrate that the application of Fibrin Sealant Grifols provides a measurable benefit when compared to hemostasis achieved through conventional surgical technique (suture) and by standard hemostatic action, such as mechanical pressure through manual compression. This study has a Preliminary Part (I) in which all subjects are treated with Fibrin Sealant Grifols and a Primary Part (II) in which subjects are randomized in a 2:1 ratio to either Fibrin Sealant Grifols or manual compression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline (within 24 hours prior to surgical procedure).
- •Require elective (non-emergency), primary, open (non-laparoscopic; non-endovascular) peripheral vascular surgery.
- •Require one of the following peripheral vascular procedures involving proximal end-to-side arterial anastomosis utilizing coated or uncoated Polytetrafluoroethylene grafts: a) Femoral-femoral bypass grafting, b) Femoral-popliteal bypass grafting, c) Femoral-distal bypass grafting, d) Ilio-iliac bypass grafting, e) Ilio-femoral bypass grafting, f) Ilio-popliteal bypass grafting, g) Aorto-iliac bypass grafting, h) Aorto-femoral bypass grafting, i)Axillo-femoral bypass grafting, and j) Upper extremity vascular access for hemodialysis.
- •A target bleeding site can be identified.
- •Target bleeding site has moderate arterial bleeding.
排除标准
- •Undergoing a re-operative procedure.
- •Undergoing other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed).
- •Have an infection in the anatomic surgical area.
- •Have a history of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product.
- •Have previous known sensitivity to any Fibrin Sealant Grifols, heparin, or protamine component.
- •Females who are pregnant or nursing a child at Baseline (within 24 hours prior to surgical procedure).
- •Have undergone a therapeutic surgical procedure within 30 days from the screening visit.
- •Target bleeding site cannot be identified.
- •Target bleeding site has mild or severe arterial bleeding.
- •Occurrence of 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.
研究组 & 干预措施
Fibrin Sealant Grifols
Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).
干预措施: Fibrin Sealant Grifols (Biological)
Manual Compression
Direct manual compression of target bleeding site with gauze/laparotomy pads.
干预措施: Manual Compression (Procedure)
结局指标
主要结局
Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start
时间窗: From start of treatment until 4 minutes after treatment start
Subjects achieving hemostasis at the target bleeding site by 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.
次要结局
- Time to Hemostasis (TTH)(From start of treatment until 10 minutes after treatment start)
- Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points(From start of treatment until 10 minutes after treatment start)
- Prevalence of Treatment Failures(From start of treatment until 10 minutes after treatment start)