Feasibility and Safety of Thrombosomes® on Time to Hemostasis in Patients Undergoing Emergency Surgery for Thoracic Aortic Dissections - a Randomized, Controlled, Open-label Investigator-initiated Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Time to hemostasis during surgery
研究概览
简要总结
The hypothesis is that administration of Thrombosomes® (TBX®) as hemostatic support when terminating the cardiopulmonary bypass (CPB) in patients undergoing emergency surgery for acute thoracic aortic dissection (aTAD) is safe and least as effective when compared to standard Platelet Concentrates (stPC).
详细描述
The study is designed as an exploratory phase 2a, single-center randomized, controlled pilot investigator-initiated trial of administration of Thrombosomes® (TBX®) versus standard platelet concentrates (stPC) in 20 aTAD patients per arm. The patients will be enrolled in the study over a period of 15 months.
TBX® is a novel, human platelet (thrombocyte) derived lyophilized (freeze dried) hemostatic blood product for treatment of bleeding due to thrombocytopenia, dysfunctional platelet disorders or platelet consumption.
The patients will be randomized to administration of either TBX®, or stPC, as part of the Massive Transfusion Protocol (MTP) at the time of termination of the cardiopulmonary bypass (CPB) in addition to standard goal-directed hemostatic optimization based on results from thrombelastography (TEG).
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
盲法说明
Open label treatment. Only statistician performing the data analysis will be blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient eligible for emergency surgery on cardiopulmonary bypass pump for acute thoracic aortic dissections
- •Age ≥ 18 years
排除标准
- •Documented refusal of blood transfusion
- •Aortic dissection due to trauma
- •Withdrawal from active therapy
- •Known hypersensitivity to TBX: the active substance, any of the excipients
- •Pregnancy (non-pregnancy confirmed by patient being postmenopausal (women >55 years of age) or having a negative urine-hCG).
结局指标
主要结局
Time to hemostasis during surgery
时间窗: During procedure
Defined by initiation of chest closure (temporary or final closure), the placement of the first sternal wire or wound vac (ioban or film), from administration of full dose protamine.
次要结局
- Bleeding in chest tubes and mediastinal drainages on arrival in the ICU(Average 3 hours)
- Number of patients needing re-do surgery due to hemorrhage(24 hours)
- Total number of blood product use during the first 24 hours in the ICU(24 hours)
- Renal replacement free days(30 days)
- Bleeding during surgery(During procedure)
- Bleeding in mL in chest tube and mediastinal drainage at 24 hour after arrival in the ICU(24 hours)
- Total number of blood product use during surgery(During procedure)
- Total units of blood product use during the first 24 hours in the ICU(24 hours)
- Length of stay in hospital(30 days)
- Symptomatic thrombo-embolic events(30 days)
- Serious adverse reactions/events(12 days)
- Total volume of blood product use during surgery(During procedure)
- Hemostatic product use during surgery(During procedure)
- Mortality(30 days)
- Bleeding in mL/kg in chest tube and mediastinal drainage at 24 hour after arrival in the ICU(24 hours)
- Length of stay in ICU(30 days)
- Sequential Organ Failure Assessment (SOFA) score during stay in ICU within 12 days(12 days)
- Vasopressor free days within 30 days(30 days)
- Ventilator free days(30 days)
研究者
Jakob Stensballe, MD, PhD
Head of research
Rigshospitalet, Denmark