Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this study, our aim is to investigate the role of tranexamic acid for modulating the inflammation in patients with traumatic brain injury (TBI).
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group C | Placebo Comparator | 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 | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with decreased the inflammatory response | Percentage of patients with decreased the inflammatory response, as assessed by NLR measurements | 48 hours post-interventional (either placebo or TXA) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Omar Soliman | Contact | 01101266040 | omar@aun.edu.eg |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut university hospital | Recruiting | Asyut | Assuit | Assuit universi | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tranexamic acid | Drug | Giving TXA (loading dose of 1gm of TXA, followed by a 1gm of maintenance dose over 8 hours for 48 h). |
|
|
| D017670 |
| Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |