Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05323149 |
Other study ID # |
17101636 |
Secondary ID |
|
Status |
Recruiting |
Phase |
Phase 3
|
First received |
|
Last updated |
|
Start date |
May 18, 2022 |
Est. completion date |
October 15, 2024 |
Study information
Verified date |
December 2023 |
Source |
Assiut University |
Contact |
Omar Soliman |
Phone |
01101266040 |
Email |
omar[@]aun.edu.eg |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
In this study, our aim is to investigate the role of tranexamic acid for modulating the
inflammation in patients with traumatic brain injury (TBI).
Description:
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
1. C-reactive protein (CRP), interleukin -6(IL-6), C-reactive protein/Albumin ratio (CAR),
complete blood count (CBC) for neutrophil lymphocyte ratio (NLR), platelet lymphocyte
ratio (PLR).
2. Prothrombin concentration (PC), prothrombin time (PT), activated partial thromboplastin
time (aPTT), and INR.
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.