Effects of imatinib on cerebral vasospasm and prognosis of patients with aneurysmal subarachnoid haemorrhage
| ISRCTN | ISRCTN86782233 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86782233 |
| Secondary identifying numbers | N/A |
- 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
Scientific
No.23, Youzheng Street
Nangang District
Harbin
150001
China
| Phone | +86 (0)136 0488 8921 |
|---|---|
| gaocheng8921@gmail.com |
Study information
| Study design | Prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact gaocheng8921@gmail.com or doctorgaocheng@yahoo.com.cn to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Imatinib |
| Primary outcome measure | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 15/06/2011 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
150001
China
Sponsor information
The First Affiliated Hospital of Harbin Medical University (China)
Hospital/treatment centre
Hospital/treatment centre
Heilongjiang
Harbin
150001
China
"ROR" |
https://ror.org/05vy2sc54 |
|---|
Funders
Funder type
Other
Investigator initiated and funded (China)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
