Assiut university hospital
Asyut, Assuit, Assuit universi, Egypt
Location status: Recruiting
NCT Number: NCT05323149
In this study, our aim is to investigate the role of tranexamic acid for modulating the inflammation in patients with traumatic brain injury (TBI).
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 3
Asyut, Assuit, Assuit universi, Egypt
Location status: Recruiting
This is double-blind trial, where group T will be received TXA, where group C will be received saline placebo.
In emergency room (ER), trauma patients will be assessed and managed according to our local hospital protocol. After the initial resuscitation of patients. The selection was done according to the inclusion criteria. Baseline investigations
Group T, will be received TXA (loading dose of 1gm of TXA, followed by a 1gm of maintenance dose over 8 hours for 48 h). Group C, will be received saline (loading dose of 1gm of saline 0.9%, followed by a 1gm of maintenance saline dose over 8 hours for 48 h) to monitor the post-interventional inflammatory response (CBC for NLR, PLR), CRP, IL-6, C-reactive protein/Albumin ratio (CAR), hemostasis (PC, PT, activated PTT, and international normalized ratio (INR)) and short-term outcome. Conscious level will be assessed by Glasgow come scale (GCS), delirium by Richmond Agitation-Sedation Scale (RASS score) and hemodynamics will be continuously monitored. Patients will be monitored and managed in intermediate or intensive care unit. Adverse effects and complications will be recorded and managed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Giving saline (loading dose of 1gm of saline 0.9%, followed by a 1gm of maintenance saline dose over 8 hours for 48 h).
Other names: Normal saline
Giving TXA (loading dose of 1gm of TXA, followed by a 1gm of maintenance dose over 8 hours for 48 h).
Other names: Cyclokapron
Time frame: 48 hours post-interventional (either placebo or TXA)
Percentage of patients with decreased the inflammatory response, as assessed by NLR measurements
Contact information is provided by the study sponsor or research team.
Assiut University
Other
The Impact of Early Use of Tranexamic Acid in Traumatic Brain Injury Upon the Inflammatory Response and Outcome
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