Benefits of Amantadine in Patients With Coma State

Dokuz Eylül University (DEU)

Status: Unknown

Conditions: Coma; Prolonged; Amantadine

Treatments: Drug: amantadine sulphate

Study type: Observational

Funder types: Other

Identifiers

NCT03443037

265-SBKAEK

Details and patient eligibility

About

The study was a single center observational-prospective study and approved by local ethics committee. Patients in coma state due to traumatic brain injury, cardiac arrest or ischemic stroke who are older than 18 years of age were included in the study. Patients who received amantadine 200mg/day for fourteen days according to ICU protocols decided by primary physician formed the amantadine group, and the rest of the subjects were included in the control group. All patients were evaluated for Glasgow Coma Score, JFK Coma Recovery Scale and Disability Rating Scale once a week for three months.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years, ≤ 65 years
• GCS score ≤ 8
• Coma state due to ischemic stroke, brain hemorhage, anoxic brain damage

Exclusion criteria

• <18 years, > 65 years
• Patients admitted to the critical care without diagnosis of coma state
• Patients admitted to critical care with coma state that are not duo to ischemic stroke, brain hemorhage, anoxic brain damage
• Metastatic malignant neoplazm
• Congenital or acquired brain function problem (cerebral palsy, autism etc)
• Patients with amantadine allergy
• Progressive degenerative diseases (Alzheimer, Parkinson diseases etc)

Trial design

56 participants in 2 patient groups

Amantadine group

Description:

Patients admitted to the critical care with diagnosis of coma state who have received amantadin 200 mg / day for fourteen days according to İCU protocols decided by primary physician

Treatment:

Drug: amantadine sulphate

Control group

Description:

Patients admitted to the critical care with diagnosis of coma state who haven't received amantadin