Methylprednisolone for primary intracerebral hemorrhage: a randomized double-blind, placebo-controlled trial

• Register: ChiCTR
• Last refreshed on: 28 April 2013
• Main ID: ChiCTR-TRC-10001141
• Date of registration: 2011-01-05
• Primary sponsor: West China Hospital, Sichuan University
• Public title: Methylprednisolone for primary intracerebral hemorrhage: a randomized double-blind, placebo-controlled trial
• Scientific title: Methylprednisolone for primary intracerebral hemorrhage: a randomized double-blind, placebo-controlled trial
• Date of first enrolment: 2011-03-01
• Target sample size: Experimental group:50;Control group:50;Total:100;
• Recruitment status: Pending
• URL: http://www.chictr.org/en/proj/show.aspx?proj=264
• Study type: Interventional
• Study design: Randomized parallel control

Countries of recruitment

China

Contacts

• Name: Xi Li

• Name: Chao You, Ming Liu

Key inclusion & exclusion criteria

Inclusion criteria: 1. Age from 18 to 80 years
2. Acute spontaneous supratentorial ICH
3. Haematoma volume between 10 to 30ml
4. GCS score>8
5 Admission within 24 hours of ictus
Exclusion criteria: 1. The haemorrhage was probably due to an aneurysm or an angiographically proven intracranial vascular malformation or tumour stroke
2. Associated with head injury or traumatic history
3. Patients with mutiple intracerebral hemorrhage
4. Patients who had severe pre-existing physical and/or mental disability
5. Coagulation disorders or history of anticoagulant
6. History of gastric ulcer or diabetes mellitus
7. Hypoimmunity or infection
8. Patients who have reveived long-term glucocorticord treatment.
9. Patients who received drugs which may influnce blood sugar, immunity, gastrointestinal function or the methylprednisolone metabolism 1month prior to the enrollment
10. Hepatic and/or renal dysfunction

Age minimum: 18
Age maximum: 80
Gender: Both

Health Condition(s) or Problem(s) studied

Acute primary supratentorial intracerebral hemorrhage

Intervention(s)

Experimental group:Methylprednisolone 80 mg via intravenous infusion once per 12 hours for 72 hours+conventional medical treatment;Control group:Placebo+conventional medical treatment;Total:;

Primary Outcome(s)

Edema aroud the hematoma, Mortality, GOS score, Modified Rankin Scale, NIHSS Scale;

Secondary Outcome(s)

Hepatic and renal function, electrolyte, size of hematoma, vital indications;

Source(s) of Monetary Support

Self-funding

Secondary Sponsor(s)

West China Hospital, Sichuan University