Investigating the effect of indomethacin on the clinical outcome of patients with severe non-hemorrhagic traumatic brain injury, a randomized placebo-controlled study

Phase 3

• Conditions: Traumatic brain injury.; Concussion; S06.0

• Registration Number: IRCT20220521054939N1
• Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Registration of informed consent of the first degree patient to participate in the study
Age 16 to 70 years
Severe traumatic brain injury with closed or penetrating mechanism
High resistant ICP
8 =GCS

Exclusion Criteria

Pregnancy
Brain death
Coagulation disorders
History of gastrointestinal bleeding or active bleeding
History of peptic ulcer
Acute kidney injury
History of allergies to nonsteroidal anti-inflammatory drugs
Clinical signs and symptoms of renal failure or its history
Hyperkalemia
Liver failure

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severe traumatic brain injury. Timepoint: It will be measured again one month and 6 months after administration. Method of measurement: Visual Analogue Scale.

Secondary Outcome Measures

Name	Time	Method
Degree of disability or dependence in daily activities. Timepoint: It will be measured again one month and 6 months after administration. Method of measurement: Visual Analogue Scale.;Severe traumatic brain injury. Timepoint: It will be measured again one month and 6 months after administration. Method of measurement: Visual Analogue Scale.