The Haemostatic Effect of Deep-frozen Platelets Versus Room Temperature Stored Platelets in the Treatment of Traumatic or Vascular Bleeding. MAFOD: a Randomized Controlled Non-inferiority Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 158
- 主要终点
- Percentage of patients that achieved haemostasis and show signs of life.
研究概览
简要总结
Primarily due to its logistical advantages The Netherlands Armed Forces (NLAF) have been successfully using deep frozen (-80°C) platelets (DTC) for the treatment of (massive) bleeding trauma patients in austere environments since 2001. However, high-quality evidence for effectiveness and safety in the treatment of these type of patients is currently lacking. The MAssive transfusion of Frozen bloOD (MAFOD) trial is therefore designed to compare the haemostatic effect of DTCs versus room temperature stored platelets (RSP) in the treatment of trauma- and vascular bleeding.
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
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of 12 years or older
- •Alive at hospital presentation
- •Requiring massive transfusion including platelets
- •Signed (deferred) consent
排除标准
- •Known pregnancy
研究组 & 干预措施
Deep-frozen platelets
-80°C stored fresh, leukocyte depleted (leukodepleted) platelet concentrates.
干预措施: Deep-frozen platelets (Drug)
Room-temperature stored platelets
+22°C stored platelets
干预措施: Deep-frozen platelets (Drug)
结局指标
主要结局
Percentage of patients that achieved haemostasis and show signs of life.
时间窗: At six hours
Achieved haemostasis (yes/no) as defined a patient no further require erythrocyte transfusions for two hours;
次要结局
- Time to heamostasis in minutes after arrival to the hospital(24 hours)
- Laboratory haematocrit(0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge)
- Mortality at Emergency Department(During hospital stay)
- Transfused erythrocyte concentrates (EC) / Red Blood Cells (RBC)(Measurement in 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge)
- Transfused plasma(Measurement in 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge)
- Transfused platelets(Measurement in 0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge)
- Fibrinogen administration in grams(0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge)
- Laboratory haemoglobin(0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge)
- Laboratory platelet count(0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours and 72-hours - 30 days or discharge)
- Coagulation parameter Fibrinogen (clauss)(0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours)
- Overall mortality(24 hours, 30 days)
- Occurence of transfusion reactions(24 hours, 30 days)
- Coagulation parameter INR(0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours)
- Coagulation parameter aPTT(0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours)
- Coagulation parameter viscoelastic testing rotational tromboelastometry (ROTEM)(0-1 and 1-3 and 3-6 and 6-12 and 12-24 and 24-72 hours)
- Mortality after surgey(Emergency Department)
- Time of death(During hospital stay)
- Hospital length of stay(24 hours, 30 days)
- ICU length of stay(24 hours, 30 days)