Doxycycline in Acute Traumatic Brain Injury

Status Completed

Clinical Trial Summary

evaluate the impact of Doxycycline on both clinical outcome and blood levels of NSE in patients with TBI.

Clinical Trial Description

1. Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damnhour University. 2. All Participants agreed to take part in this clinical research and provide informed consent. for unconscious participants, the informed consent was obtained from their legally authorized representative. 3. Patients with moderate to severe TBI will be enrolled from Tanta university hospitals. 4. Serum samples will be collected for measuring the biomarkers. 5. Our design is randomized, controlled study. 6. All enrolled patients will be divided into 2 groups, Group (1) 25 patients that receive doxycycline 100 mg twice daily, either orally or through a nasogastric tube for 5 days, and group (2) will be 25 patients will receive placebo in addition to the standard treatment. 7. All patients will be followed up during ICU period. 8. Statsicial tests appropriate to the study design will be conducted to evaluate the significance of the results. 9. Measuring outcome: the primary outcome is the change in the serum level of acute brain injury biomarkers. 10. Results, conclusions, discussion and recommendations will be given. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04239755
Study type	Interventional
Source	Damanhour University
Contact
Status	Completed
Phase	Phase 4
Start date	February 1, 2020
Completion date	October 30, 2020

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