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 Parenchymous Tissue Open Surgeries
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 325
- 试验地点
- 65
- 主要终点
- Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start
研究概览
简要总结
This study is designed to assess the safety and efficacy of Fibrin Sealant Grifols in patients undergoing open surgical procedures where bleeding may be present on parenchymous tissue (e.g., solid abdominal organs such as the liver). The purpose of this study is to demonstrate that Fibrin Sealant Grifols is not inferior to commercially-available oxidized cellulose pads (Surgicel®) in providing benefit in the time to hemostasis (i.e, the stoppage of bleeding). This study has a Preliminary Part (I) for study teams to become familiar with the application of Fibrin Sealant Grifols and to assess safety and a Primary Part (II) to assess the safety and efficacy of Fibrin Sealant Grifols. In both parts of the study, patients will be randomized in a 1:1 ratio to either Fibrin Sealant Grifols or Surgicel.
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), open (non-laparoscopic), hepatic resection (anatomic or non-anatomic resections of at least one anatomical hepatic segment, or equivalent tissue volume).
- •A target bleeding site can be identified.
- •Target bleeding site is identified on the cut raw liver surface (resection area).
- •Target bleeding site has moderate bleeding according to the Investigator's judgment.
排除标准
- •Require hepatic resection due to trauma.
- •Infection in the anatomic surgical area.
- •History of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product.
- •Previous known sensitivity to any Fibrin Sealant Grifols component or any Surgicel® component.
- •Females who are pregnant or nursing a child at Baseline (within 24 hours prior to surgical procedure).
- •Receiving an organ transplant during the same surgical procedure.
- •Undergone a therapeutic surgical procedure within 30 days from the screening visit.
- •A target bleeding site cannot be identified.
- •The target bleeding site has a mild or severe bleeding.
- •Occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.
- •Application of any topical haemostatic material on the resection surface of the liver prior to application of study treatment.
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
- Proportion of Subjects Achieving Hemostasis by Three Minutes After Treatment Start(From start of treatment until 3 minutes after treatment start)
- Time to Hemostasis(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)