Edaravone Dexborneol for Treatment of Hypertensive Intracerebral Hemorrhage

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

pending

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Collaborator: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Treatments: Edaravone

Criteria

Inclusion Criteria:

• Written informed consent from the patient or legally acceptable representative

• Males and females

• Diagnose as hypertensive intracerebral hemorrhage

• Onset of symptoms within 6~48 hours

• Position of bleeding major in basal ganglia

• The sum of scores on items 5 and 6 on the NIHSS were >= 2 at baseline and the total score (items 1-11) was >=6 and <=20

• Volume of Hematoma <= 30 ml

• Premorbid mRS score of 0 or 1

Exclusion Criteria:

• Allergy to known study drugs or excipients

• Experienced stroke in latest 3 month

• Volume of Hematoma > 5 ml in other bleeding position

• Obstructive hydrocephalus

• Any diagnosis as other than hypertensive ICH

• Unconsciousness

• Severe concurrent illness with life expectancy less than 90 days

• Pregnancy or breast-feeding