The Influence of Thromboelastometry-identified Haemostatic Changes on Haemorrhagic Progression of Intracranial Injury and Clinical Outcome in Patients With Isolated Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
A prospective open-label case-control study will be performed aiming to assess the utility of thromboelastometry (ROTEM) for identification of hemostatic changes, goal-directed coagulation management, and prognosis of intracranial hemorrhagic injury progression as well as clinical outcome in patients with isolated traumatic brain injury. Patients undergoing craniotomy to treat traumatic brain injury will be enrolled. All patients will undergo standard perioperative coagulation analysis (APTT, PT, INR, fibrinogen levels, platelet count), whereas ROTEM-guided group will additionally be tested with ROTEM. "Cases" will be managed according to a ROTEM-based algorithm, and "Controls" will be treated as usual (based on clinical judging). Comparative analysis of acquired demographic, clinical and laboratory data will be performed. The investigators believe that ROTEM results could provide better insight into perioperative coagulation changes, be beneficial to patient blood management, and result in better outcome.
详细描述
Aim of the study:
To assess the utility of thromboelastometry for identification of hemostatic changes, goal-directed coagulation management, and prognosis of intracranial hemorrhagic injury progression as well as clinical outcome in patients with isolated traumatic brain injury.
Objectives:
To evaluate perioperative prevalence and characteristics of thromboelastometry identified coagulopathy in neurosurgical patients with isolated traumatic brain injury; To assess the correlation between routine laboratory test results and thromboelastometric findings; To evaluate the influence of thromboelastometric findings and goal-directed coagulation management on the progression of intracranial hemorrhagic injury; To evaluate the utility of thromboelastometry for goal-directed coagulation management, and its possible influence on clinical outcome.
Study background:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Isolated traumatic brain injury (within 48 hours) (AIS head >= 3)
- •Urgent craniotomy is necessary
- •A written informed consent is acquired from the patient or his/her representative
排除标准
- •Refusal / inability to acquire an informed consent
- •Significant trauma to other body regions (AIS other regions >= 3)
- •Data on significant chronic hepatic or hematologic illness
- •Use of oral anticoagulants or antiplatelet agents
- •Pregnancy
研究组 & 干预措施
Conventional therapy
Intraoperative haemostatic treatment is based on conventional coagulation assays.
Goal-directed therapy
Thromboelastometry-guided haemostatic treatment is provided intraoperatively.
干预措施: Thromboelastometry-guided haemostatic treatment (Other)
结局指标
主要结局
Mortality
时间窗: 30 days
Mortality of patients in both groups
Early neurological state according to Glasgow coma scale
时间窗: 30 days
Glasgow coma scale (GCS) is used to objectively assess the level of consciousness after neurological injury according to best eye (range 1 to 4), verbal (range 1 to 5) and motor (range 1 to 6) response of the patient. Eye, verbal and motor scores are summed to give the total Glasgow coma score (range 3 to 15). The lowest possible GCS (the sum) is 3 (deep coma or death), while the highest is 15 (fully awake person).
次要结局
- Clinical outcome according to Glasgow outcome score(Up to 1 year)
- Coagulation abnormalities on conventional coagulation assays and ROTEM(72 hours)
- Progressive hemorrhagic injury(30 days)
研究者
MARIUS RIMAITIS
PhD student
Lithuanian University of Health Sciences