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NCT Number: NCT05323149

Tranexamic Acid in Traumatic Brain Injury

In this study, our aim is to investigate the role of tranexamic acid for modulating the inflammation in patients with traumatic brain injury (TBI).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Assiut university hospital

Asyut, Assuit, Assuit universi, Egypt

Location status: Recruiting

Location contact

Omar Soliman

CONTACT

[email protected]

About this study

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

  • 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).
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline

Other

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

Tranexamic Acid

Drug

Giving TXA (loading dose of 1gm of TXA, followed by a 1gm of maintenance dose over 8 hours for 48 h).

Other names: Cyclokapron

Primary outcomes

  1. Percentage of patients with decreased the inflammatory response

    Time frame: 48 hours post-interventional (either placebo or TXA)

    Percentage of patients with decreased the inflammatory response, as assessed by NLR measurements

Study contacts

Contact information is provided by the study sponsor or research team.

Omar Soliman

CONTACT

[email protected]

01101266040

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 12, 2022
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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