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Tranexamic Acid in Traumatic Brain Injury

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05323149
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
16.9
Anticipated Duration (Months)
7.1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Saline
  • Drug: Tranexamic acid
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Impact of Early Use of Tranexamic Acid in Traumatic Brain Injury Upon the Inflammatory Response and Outcome
Actual Study Start Date :
May 18, 2022
Anticipated Primary Completion Date :
Oct 10, 2023
Anticipated Study Completion Date :
Oct 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Group C

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).

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).
Other Names:
  • Normal saline

    		•
    Experimental: Group T

    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).

    Drug: Tranexamic acid
    Giving TXA (loading dose of 1gm of TXA, followed by a 1gm of maintenance dose over 8 hours for 48 h).
    Other Names:
  • Cyclokapron

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut university hospital Assiut Assuit Egypt Assuit universi

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Omar Makram Soliman, Lecturer of anesthesia and ICU, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05323149
    Other Study ID Numbers:
    • 17101636
    First Posted:
    Apr 12, 2022
    Last Update Posted:
    May 25, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Brain Injuries
    Brain Injuries, Traumatic
    Tranexamic Acid

    Study Results

    No Results Posted as of May 25, 2022