Initial Resuscitation With Albumin in Hemorrhagic Shock to Reduce Positive Fluid Balance: A Randomized Controlled Trial (ABSOLUTE Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Total fluid balance until physical hemostasis of bleeding is confirmed (ml)
研究概览
简要总结
This study is designed to evaluate the effect of early albumin transfusion within massive transfusion protocol on fluid balance and reduced requirement of transfusion.
详细描述
Eligible patients who require massive transfusion will be randomized in a single-blind manner (participant) in a 1:1 ratio to Conventional Massive Transfusion Pro. tocol group (C-MTP) or Albumin Massive Transfusion Protocol group (A-MTP). When MTP is initiated according to the result of randomization, all patients(or a legal guardian) are informed about the study and potential risks and benefits. Study will be continued only in patients who give informed consent.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (19 or older)
- •Admitted or planned to admit surgical intensive care unit
- •Patients with decreased hemoglobin level more than 20% from baseline within 12 hours, Or
- •Patients who are suspected bleeding and hemodynamically unstable requiring more than 0.05mcg/kg/min of norepinephrine infusion to maintain mean blood pressure higher than 65mmHg
排除标准
- •Contraindicated to albumin product
- •patients with risk factors of increased circulatory volume (heart failure, pulmonary edema, end-stage renal disease with oliguria)
- •patients with hemolytic anemia
- •History of anaphylactic reaction to blood product
研究组 & 干预措施
Albumin-massive transfusion protocol
At the initiation of MTP, 200ml of 20% albumin will be infused followed by transfusion of packed RBC:FFP:Platelet concentrate with ratio of 1:1:1.
干预措施: Albumin solution (Drug)
Conventional-massive transfusion protocol
At the initiation of MTP, Balanced crystalloid will be infused followed by transfusion of packed RBC:FFP:Platelet concentrate with ratio of 1:1:1. Albumin will be transfused according to the serum albumin level.
干预措施: Balanced crystalloid solution (Drug)
结局指标
主要结局
Total fluid balance until physical hemostasis of bleeding is confirmed (ml)
时间窗: Time from the initiation of massive transfusion protocol to physical hemostasis of bleeding was confirmed, up to 48 hours after initiation of massive transfusion protocol
Total fluid balance (Total fluid infused - Total output(urine output, bleeding, drainage, or etc.) until physical hemostasis of bleeding is confirmed (e.g. embolization, surgical exploration and ligation of vessel)
次要结局
- Total length of ICU and hospital stay (days)(When discharge from ICU or hospital for any cause (days), through study completion, an average of 4 year)
- Acute kidney injury within 2 days of massive transfusion(up to 2 days of MTP)
- Time from the initiation of massive transfusion protocol to reversal of shock (min)(Time from the initiation of massive transfusion protocol to mean blood pressure was maintained higher than 65mmHg without vasopressor (min), up to 48 hours after initiation of massive transfusion protocol)
- Total amount of fluid until physical hemostasis of bleeding is confirmed (ml)(Time from the initiation of massive transfusion protocol to physical hemostasis of bleeding was confirmed, up to 48 hours after initiation of massive transfusion protocol)
- In-hospital mortality(When mortality occurred, through study completion, an average of 4 year)
- 7-day mortality(Within 7 days since the initiation of the massive transfusion protocols)
- 28-day mortality(Within 28 days since the initiation of the massive transfusion protocols)
- Major pulmonary complication within 2 days of massive transfusion(up to 2 days of MTP)
- Transfusion-related adverse event(up to 2 days of MTP)
研究者
Seung-Young Oh
Clinical associate professor
Seoul National University Hospital