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Tranexamic Acid in Traumatic Brain Injury

Primary Purpose

Inflammatory Response

Status

Recruiting

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Saline

Tranexamic acid

About this trial

This is an interventional treatment trial for Inflammatory Response

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Assiut university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Group C

Group T

Arm Description

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

Outcomes

Primary Outcome Measures

Percentage of patients with decreased the inflammatory response

Percentage of patients with decreased the inflammatory response, as assessed by IL-6 measurements

Secondary Outcome Measures

Full Information

NCT ID

NCT05323149

First Posted

March 27, 2022

Last Updated

May 18, 2022

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT05323149

Brief Title

Tranexamic Acid in Traumatic Brain Injury

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 18, 2022 (Actual)

Primary Completion Date

October 10, 2023 (Anticipated)

Study Completion Date

October 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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).

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammatory Response

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group C

Arm Type

Placebo Comparator

Arm Description

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).

Arm Title

Group T

Arm Type

Experimental

Arm Description

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).

Intervention Type

Other

Intervention Name(s)

Saline

Other Intervention Name(s)

Normal saline

Intervention Description

Giving saline (loading dose of 1gm of saline 0.9%, followed by a 1gm of maintenance saline dose over 8 hours for 48 h).

Intervention Type

Drug

Intervention Name(s)

Tranexamic acid

Other Intervention Name(s)

Cyclokapron

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of patients with decreased the inflammatory response

Description

Percentage of patients with decreased the inflammatory response, as assessed by IL-6 measurements

Time Frame

48 hours post-interventional (either placebo or TXA)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Omar Soliman

Phone

01101266040

omar@aun.edu.eg

Facility Information:

Facility Name

Assiut university hospital

City

Assiut

State/Province

Assuit

ZIP/Postal Code

Assuit universi

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Omar Soliman

omar@aun.edu.eg

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Tranexamic Acid in Traumatic Brain Injury

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