Citicoline on Barthel Index in Patients with Moderate and Severe Traumatic Brain Injury

Phase 3

Recruiting

• Conditions: Patients with severe and moderate brain injury.; Diffuse traumatic brain injury; S06.2X

• Registration Number: IRCT20200609047706N1
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients with severe and moderate traumatic brain injury based on GCS less than 12
Patients should be without traumatic major lesions in the thorax, abdomen, and limbs
Patients without heart problems
Have the satisfaction to enter the study

Exclusion Criteria

Previous history of brain Injury, stroke, or neurological disease
Contraindications or sensitivity to Citicoline
The presence of comorbidities such as cardiovascular, renal, hepatic, and malignant history
Traumatic brain injury, major trauma to the thorax, abdomen and other organs
Unstable hemodynamics
Pregnancy
Surgical interventions were performed within the first 24 hours after trauma
cardiopulmonary resuscitation was performed within the first 24 hours after trauma
Dissatisfaction of the patient to enter the study and her/his death during the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improving the patient's barthel index. Timepoint: Upon arrival, one month, three months and six months. Method of measurement: Barthel Questionnaire.