The Influence of Thromboelastometry-identified Haemostatic Changes on Haemorrhagic Progression of Intracranial Injury and Clinical Outcome in Patients With Isolated Traumatic Brain Injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 142
- Locations
- 2
- Primary Endpoint
- Mortality
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Mortality
Time Frame: 30 days
Mortality of patients in both groups
Early neurological state according to Glasgow coma scale
Time Frame: 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).
Secondary Outcomes
- 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)
Investigators
MARIUS RIMAITIS
PhD student
Lithuanian University of Health Sciences