Massive Transfusion in Children: a Platform RCT of Whole Blood Compared to Component Therapy and Tranexamic Acid to Placebo in Life-threatening Traumatic Bleeding
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 23
- 主要终点
- 24 hours all cause mortality
研究概览
简要总结
The MATIC-2 is a multicenter clinical trial enrolling children who are less than 18 years of age with hemorrhagic shock potentially needing significant blood transfusion.
The primary objective of the clinical trial is to determine the effectiveness of Low Titer Group O Whole Blood (LTOWB) compared to component therapy (CT), and Tranexamic Acid (TXA) compared to placebo in decreasing 24-hour all-cause mortality in children with traumatic life threatening hemorrhage.
详细描述
The MATIC-2 trial is a Bayesian, randomized, multicenter, adaptive platform phase III trial. The trial will include injured children with hemorrhagic shock anticipated to require massive blood transfusion, who will be randomized to receive either LTOWB or CT and Tranexamic Acid or placebo.
The study investigators hypothesize that the use of LTOWB is non-inferior and/or superior for 24-hour mortality and that LTOWB does not increase the risk of adverse events or outcomes, such as thrombotic events, compared to CT.
The investigators also hypothesize that the use of TXA is superior for 24-hour mortality and does not increase the risk of adverse events or outcomes, such as thrombotic events, compared to placebo.
Objectives:
The primary objectives are to:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The University of Pittsburgh Medical Center Investigational Research Pharmacy will provide each site the placebo and TXA. The research pharmacy at each site will draw the dose syringes. They will be blinded with a label indicating either drug A or B, and the pharmacy will log which patients received TXA or placebo, with all drugs labeled as investigational products.
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Inclusion Criteria:
- •Children, defined as less than estimated18 years of age with traumatic injury
- •MTP activation for confirmed or suspected active life-threatening traumatic bleeding
- •Confirmed or suspected active life-threatening traumatic bleeding with at least 2 of 3 of the following criteria:
- •Hypotension for age (< 5% tile)
- •Tachycardia for age (>95th % tile)
- •Traumatic injury with exam findings consistent with severe bleeding (e.g., penetrating injury, hemothorax, distended abdomen with bruising, amputation of limb).
排除标准
- •Patient with devastating traumatic brain injury not expected to survive due to magnitude of injury (example: Transhemispheric gunshot wound with signs of herniation, GCS score of 3 with fixed and dilated pupils)
- •MTP activated but no blood products given
- •Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving randomized blood products)
- •Patients who are known or suspected to be pregnant on clinical examination
- •Known prisoners as defined in protocol
- •Known ward of the state
- •Isolated hanging, drowning or burns
- •Previous enrollment in MATIC-2
- •Prior study opt-out with bracelet
- •Exclusion Criteria for the TXA/Placebo Domain
- •Prehospital or pre-enrollment use of TXA
- •Greater than 3 hours since time of injury
- •History of seizure after the injury event
- •Known allergy or hypersensitivity reaction to TXA
研究组 & 干预措施
Group 3 (CT+TXA)
Concurrent administration of CT and TXA
干预措施: Component Therapy (CT) (Biological)
Group 2 (LTOWB+Placebo)
Concurrent administration of LTOWB and Placebo
干预措施: Placebo (Drug)
Group 2 (LTOWB+Placebo)
Concurrent administration of LTOWB and Placebo
干预措施: Low Titer Group O Whole Blood (LTOWB) (Biological)
Group 3 (CT+TXA)
Concurrent administration of CT and TXA
干预措施: Tranexamic Acid (TXA) (Drug)
Group 1 (LTOWB+TXA)
Concurrent administration of LTOWB and TXA
干预措施: Low Titer Group O Whole Blood (LTOWB) (Biological)
Group 1 (LTOWB+TXA)
Concurrent administration of LTOWB and TXA
干预措施: Tranexamic Acid (TXA) (Drug)
Group 4 (CT+Placebo)
Concurrent administration of CT and Placebo
干预措施: Placebo (Drug)
Group 4 (CT+Placebo)
Concurrent administration of CT and Placebo
干预措施: Component Therapy (CT) (Biological)
结局指标
主要结局
24 hours all cause mortality
时间窗: 24 hours
次要结局
- 6-hour, 72-hour and 28-day survival(6, 72 hours and 28 days)
- 24 hours total blood product transfusion volumes(24 hours)
研究者
Philip Spinella
Professor of Surgery and Critical Care Medicine
University of Pittsburgh