Tranexamic Acid in Traumatic Brain Injury

Inflammatory Response Clinical Trial

Official title:

The Impact of Early Use of Tranexamic Acid in Traumatic Brain Injury Upon the Inflammatory Response and Outcome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05323149
• Other study ID #: 17101636
• Status: Recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Inflammatory Response

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)