Tranexamic Acid in Traumatic Brain Injury

Phase 3

Recruiting

• Conditions: Inflammatory Response
• Interventions: Other: Saline; Drug: Tranexamic acid

• Registration Number: NCT05323149
• Lead Sponsor: Assiut University

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2022-03-27
• Study First Submitted QC: 2022-04-11
• Study First Posted: 2022-04-12
• Study Start: 2022-05-18
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-27
• Last Update Posted: 2023-12-28
• Primary Completion: 2024-09-10
• Study Completion: 2024-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Saline	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).
Group T	Tranexamic acid	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).

Primary Outcome Measures

Name	Time	Method
Percentage of patients with decreased the inflammatory response	48 hours post-interventional (either placebo or TXA)	Percentage of patients with decreased the inflammatory response, as assessed by IL-6 measurements

Trial Locations

Locations (1)

Assiut university hospital; 🇪🇬 Assiut, Assuit, Egypt