Condition category
Circulatory System
Date applied
05/06/2011
Date assigned
02/12/2011
Last edited
02/12/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gao Cheng

ORCID ID

Contact details

No.23
Youzheng Street
Nangang District
Harbin
150001
China
+86 (0)136 0488 8921
gaocheng8921@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

Imatinib ameliorated cerebral vasospasm and improved Glasgow outcome score (GOS) at 6 months in subarachnoid haemorrhage (SAH) patients.

Ethics approval

Medical Ethics Committee,The First Affiliated Hospital of Harbin Medical University, China approved on 15th May 2011, Ref No.2011-18

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please contact gaocheng8921@gmail.com or doctorgaocheng@yahoo.com.cn to request a patient information sheet

Condition

Aneurysmal subarachnoid haemorrhage

Intervention

1. Imatinib (400mg/d) (GlivecĀ®) 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 names

Imatinib

Primary outcome measures

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 trial start date

15/06/2011

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

15/06/2011

Recruitment end date

31/12/2012

Locations

Countries of recruitment

China

Trial participating centre

No.23, Youzheng Street
Harbin
150001
China

Sponsor information

Organisation

The First Affiliated Hospital of Harbin Medical University (China)

Sponsor details

Heilongjiang
Harbin
150001
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes