NCT05568888终止3 期
A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Large Simple Trial Evaluating the Use of BE1116 (4-Factor Prothrombin Complex Concentrate [Kcentra® / Beriplex®]) to Improve Survival in Patients With Traumatic Injury and Acute Major Bleeding
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- CSL Behring
- 入组人数
- 1,366
- 试验地点
- 111
- 主要终点
- Proportion of Participants With All-cause 6-hour Mortality
研究概览
简要总结
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, large simple trial to investigate the efficacy and safety of a single intravenous (IV) infusion of BE1116 in subjects who have traumatic injury, with confirmed or suspected acute major bleeding and / or predicted to receive a large volume blood product transfusion.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(a) Estimated age ≥ 15 years. Older minimum age is required in some locations. FOR United Kingdom: Estimated or actual age ≥ 16 years FOR Australia: Estimated or actual age ≥ 18 years AND (b) Estimated or actual weight ≥ 50 kg (110 lbs).
- •Traumatic injury with confirmed or suspected acute major bleeding and/or Revised Assessment of Bleeding and Transfusion (RABT) score ≥ 2
- •Activation of massive transfusion protocol
排除标准
- •Healthcare professional cardiopulmonary resuscitation including chest compressions for ≥ 5 consecutive minutes at any time before randomization
- •Isolated penetrating or blunt cranial injury, or exposed brain matter
- •Isolated burns estimated to be > 20% total body surface area or suspected inhalational injury
- •Known anticoagulation treatment or a history of a TEE, within the past 3 months.
研究组 & 干预措施
BE1116
Experimental
Administration by IV infusion
干预措施: BE1116 (Drug)
Placebo
Placebo Comparator
Administration by IV infusion
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Participants With All-cause 6-hour Mortality
时间窗: Up to 6 hours after randomization
Here, the percentage of participants with all-cause mortality has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.
次要结局
- Proportion of Participants With All-cause 24-hour In-hospital Mortality(Up to 24 hours after randomization)
- Proportion of Participants With All-cause In-hospital Mortality Up to 30 Days After Randomization(Up to 30 days after randomization)
- Proportion of Participants Who Underwent Surgical or Interventional Radiological Procedures to Stop Bleeding Related to the Primary Injury(Up to 24 hours after randomization)
- Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs)(Up to 30 days after randomization)
- Number of Participants With In-hospital Overall and Related Thromboembolic Events (TEEs)(Up to 30 days after randomization)
- Number of Participants With Acute Respiratory Distress Syndrome (ARDS)(Up to 30 days after randomization)
- Number of Participants With Multiple Organ Failure(Up to 30 days after randomization)
- Number of Participants With Acute Kidney Injury (AKI) Requiring Renal Replacement Therapy(Up to 30 days after randomization)
研究者
研究点 (111)
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