Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 2
- 主要终点
- The Time to Hemostasis Measured From Start of Study Treatment to the Achievement of Hemostasis at the Target Bleeding Site (TBS), or to the End of the 10-minute Observation Period.
研究概览
简要总结
The purpose of the study is to assess efficacy and safety of HemoStyp as an adjunct for management of secondary hemostasis in the operative setting.
详细描述
This study is a prospective, non-inferiority, multi-center, randomized, open-label trial to compare HemoStyp with Surgicel® in the management of bleeding during surgery.
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
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery);
- •At time of surgery has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical;
- •Ages: Pediatric subjects 2 years to 17 years of age and adult subjects 18 years of age or older; and
- •Subjects or parent or legal guardian of the subject who are willing and able to sign consent.
排除标准
- •Physical or psychological condition which would impair study participation;
- •Indications for emergency surgery;
- •Pre-operative laboratory findings of a hematologic disorder;
- •Subjects with history of moderate to severe allergies;
- •Subjects undergoing minimally invasive laparoscopic surgery;
- •Subjects who will require platelet or fresh frozen plasma transfusion during surgery;
- •Subjects who are pregnant or breast-feeding at the time of surgery; or
- •Subjects on P2Y12 platelet inhibitor (Plavix) less than 5 days prior to surgery, warfarin or Xa inhibitors not withheld per standard protocols for the management of anticoagulants pre-operatively.
结局指标
主要结局
The Time to Hemostasis Measured From Start of Study Treatment to the Achievement of Hemostasis at the Target Bleeding Site (TBS), or to the End of the 10-minute Observation Period.
时间窗: 10 minutes
The time to hemostasis was measured from start of study treatment to the achievement of hemostasis at the target bleeding site (TBS), or to the end of the 10-minute observation period. The time to hemostasis was considered as censored at the end of the 10-minute observation period. Time to hemostasis was quantified in minutes according to its nominal time point. When re-bleeding occurred, and the cessation of bleeding is again achieved at a later time point, the effective time to hemostasis was the latter time point. The time to hemostasis was the time from start of study treatment to that last effective hemostatic time point.
次要结局
- Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes(Between 2 minutes and 10 minutes)
- Rate of Subjects Achieving Intraoperative Hemostasis at the Target Bleeding Site(Intraoperative period)
- Rate of Subjects With Intraoperative Re-bleeding From the Target Bleeding Site(Intraoperative period post hemostasis)
- Rate of Subjects Requiring Surgical Re-exploration up to 30 Days After Surgery for Re-bleeding From the Target Bleeding Site(30 days)