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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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date October 15, 2024
Est. primary completion date September 10, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Isolated traumatic brain injury patients (mild or moderate cases) - GCS > 8 - non penetrating TBI in 8 hours onset - Age = 18 years Exclusion Criteria: - Patient in cardiac arrest - Patients with coagulopathies - Renal failure patients - pregnancy - Patient refusal to participate

Study Design


Intervention

Other:
Saline
Giving saline (loading dose of 1gm of saline 0.9%, followed by a 1gm of maintenance saline dose over 8 hours for 48 h).
Drug:
Tranexamic acid
Giving TXA (loading dose of 1gm of TXA, followed by a 1gm of maintenance dose over 8 hours for 48 h).

Locations

Country Name City State
Egypt Assiut university hospital Assiut Assuit

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients with decreased the inflammatory response Percentage of patients with decreased the inflammatory response, as assessed by IL-6 measurements 48 hours post-interventional (either placebo or TXA)
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