Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
60 participants
INTERVENTIONAL
2022-05-18
2027-10-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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).
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).
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).
Tranexamic acid
Giving TXA (loading dose of 1gm of TXA, followed by a 1gm of maintenance dose over 8 hours for 48 h).
Interventions
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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).
Tranexamic acid
Giving TXA (loading dose of 1gm of TXA, followed by a 1gm of maintenance dose over 8 hours for 48 h).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* GCS \> 8
* non penetrating TBI in 8 hours onset
* Age ≥ 18 years
Exclusion Criteria
* Patients with coagulopathies
* Renal failure patients
* pregnancy
* Patient refusal to participate
18 Years
65 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Omar Makram Soliman
Lecturer of anesthesia and ICU
Locations
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Assiut university hospital
Asyut, Assuit, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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17101636
Identifier Type: -
Identifier Source: org_study_id
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