Effect of Immediate, Pre-emptive Fibrinogen Concentrate in Patients With Trauma Haemorrhage Needing Haemostatic Resuscitation - a Randomized, Controlled, Double-blinded Investigator-initiated Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- TEG® Functional Fibrinogen maximum amplitude 15 min
研究概览
简要总结
Effect of immediate, pre-emptive fibrinogen concentrate in patients with trauma haemorrhage needing haemostatic resuscitation - a randomized, controlled, double-blinded investigator-initiated pilot trial
详细描述
Objective To assess the efficacy and safety of an immediate pre-emptive first-line treatment with fibrinogen concentrate in patients with trauma haemorrhage in need of haemostatic resuscitation.
Hypothesis Immediate, pre-emptive first-line treatment of fibrinogen concentrate in trauma patients with ongoing critical haemorrhage will increase the clot strength.
Background Trauma haemorrhage remains a leading cause of morbidity and mortality. Fibrinogen is an essential endogenous component of haemostasis and the plasma level is associated to bleeding, transfusion and outcome.
Trial rationale Fibrinogen concentrate is widely used to correct acquired hypofibrinogenaemia, recommended by several international guidelines including in trauma, but evidence is lacking regarding the treatment safety and efficacy.
Trial population The trial population are patients' ≥ 18 years admitted to the Trauma Centre at Rigshospitalet with immediate need for blood transfusion at arrival and an expected need for haemostatic resuscitation with multiple transfusions during the initial resuscitation. Estimated 30-day mortality is 20 % in the population. Patients included in the trial will be temporarily incompetent because of acute, severe illness related to the ongoing critical bleeding needing multiple transfusion and immediate intervention to control bleeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Trauma patient received directly from the scene of the accident AND
- •Age ≥ 18 years AND
- •Initiated order of transfusion of at least one blood component within the 1st hour of arrival AND
- •Predicted to need transfusion package therapy during the initial resuscitation (first 2 hours) AND
- •Consent obtainable from patient or scientific guardians (independent physicians and/or next of kin
排除标准
- •Duration of > 2 hours from time of accident to arrival at trauma centre OR
- •Known anticoagulant treatment (vitamin K antagonist, dabigatran, rivaroxiban, apixaban) OR
- •Severe isolated traumatic brain injury OR
- •Moribund patient with devastating injuries and expected to die within one hour of admission OR
- •Withdrawal from active therapy OR
- •Previously, within 30 days, included in a randomized trial, if known at the time of enrolment OR
- •Known body weight < 55 kg OR
- •Any blood product prior to inclusion
研究组 & 干预措施
Fibrinogen
Immediate intravenous administration as a single dose of fibrinogen concentrate (Riastap®, CSL Behring), when haemostatic resuscitation is deemed necessary by the clinician.
干预措施: Fibrinogen (Drug)
Placebo
Saline 0.9%
干预措施: Placebo (Drug)
结局指标
主要结局
TEG® Functional Fibrinogen maximum amplitude 15 min
时间窗: 15 min after intervention
Thrombelastograph (TEG®) Functional Fibrinogen (FF) maximum amplitude (MA) in mm
次要结局
- Time to intervention or placebo(No of minutes from arrival, an expected average of 45 minutes)
- TEG® maximum amplitude 72 hours(72 hours after intervention)
- TEG® Functional Fibrinogen maximum amplitude 24 hours(24 hours after intervention)
- 30-day mortality(30 days from arrival)
- TEG® Functional Fibrinogen maximum amplitude 72 hours(72 hours after intervention)
- TEG® maximum amplitude 6 hours(6 hours after intervention)
- TEG® maximum amplitude 24 hours(24 hours after intervention)
- Anaphylaxis day 30(30 days)
- TEG® maximum amplitude 15 min(15 min after intervention)
- TEG® Functional Fibrinogen maximum amplitude 6 hours(6 hours after intervention)
- Total use of haemostatic therapy(24 hours and 27 hours)
- Time to surgical control of bleeding(No of minutes from arrival, an expected average of 120 minutes)
- TEG® Functional Fibrinogen maximum amplitude 2 hours(2 hours after intervention)
- TEG® maximum amplitude 2 hours(2 hours after intervention)
- Transfusions requirements(2, 6, 24, 72 hours and in total at day 30)
- Time to FFP and PLT transfusion(No of minutes from arrival, an expected average of 50 minutes)
- 24-hour mortality(24 hours from arrival)
- Percentage of patients receiving intervention or placebo < 1 hour of arrival(60 min from arrival)
- Thromboembolism day 30(30 days)
研究者
Jakob Stensballe, MD, PhD
Consultant Anaesthetist, MD, PhD
Rigshospitalet, Denmark