Effects of imatinib on cerebral vasospasm and prognosis of patients with aneurysmal subarachnoid haemorrhage

ISRCTN	ISRCTN86782233
DOI	https://doi.org/10.1186/ISRCTN86782233
Protocol serial number	N/A
Sponsor	The First Affiliated Hospital of Harbin Medical University (China)
Funder	Investigator initiated and funded (China)

Submission date: 05/06/2011
Registration date: 02/12/2011
Last edited: 02/12/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Gao Cheng
Scientific

No.23, Youzheng Street
Nangang District
Harbin
150001
China

Phone	+86 (0)136 0488 8921
Email	gaocheng8921@gmail.com

Study information

Primary study design	Interventional
Study design	Prospective randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effects of imatinib on cerebral vasospasm and Glasgow outcome score at 6 months in patients with aneurysmal subarachnoid haemorrhage: a prospective randomised controlled trial
Study objectives	Imatinib ameliorated cerebral vasospasm and improved Glasgow outcome score (GOS) at 6 months in subarachnoid haemorrhage (SAH) patients.
Ethics approval(s)	Medical Ethics Committee,The First Affiliated Hospital of Harbin Medical University, China approved on 15th May 2011, Ref No.2011-18
Health condition(s) or problem(s) studied	Aneurysmal subarachnoid haemorrhage
Intervention	1. Imatinib (400mg/d) (Glivec®) treatment within 72h after SAH and lasted for 7 days 2. Placebo control treatment and lasted for 7 days At 3 and 6 month, the patients were followed up
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Imatinib
Primary outcome measure(s)	1. Mortality during hospital 2. Cerebral vasospasm evaluted by Doppler on day 7 after SAH 3. Brain oedema evaluted by magnetic resonance imaging (MRI) on day 7 after SAH
Key secondary outcome measure(s)	1. Dead 2. Vegetative state: Unable to interact with environment; unresponsive 3. Severe disability : Able to follow commands / unable to live independently 4. Moderate disability: Able to live independently; unable to return to work or school 5. Good recovery: Able to return to work or school 6. Glasgow outcome score at 6 month follow up
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Key inclusion criteria	1. Written informed consent signed by parents and/or legal guardian 2. Male or female, aged 18 - 80 years 3. Aneurysm treated by surgical clipping 4. Aneurysmal subarachnoid haemorrhage within 72 hours 5. Absence of major systemic illnesses (e.g. cancer, diabetes, renal failure or heart failure) as assessed by the medical doctor, upon initial clinical assessment 6. No known or reported history of chronical illness as cancer, diabetes, chronic heart, liver or renal disease 7. No pregnancy
Key exclusion criteria	1. No written informed consent by parents/legal guardian and child 2. History of acute or severe chronic disease.(cancer, diabetes, chronic heart, liver or renal disease) 3. Participating in other clinical trials during the study 4. Pregnancy 5. Aneurysm treated by interventional coiling
Date of first enrolment	15/06/2011
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

China

Study participating centre

No.23, Youzheng Street

Harbin
150001
China

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes