Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of erythropoietin on level of circulating endothelial progenitor cells and outcome in patients after acute ischaemic stroke: a prospective randomised placebo controlled trial
Acronym
Study hypothesis
Erythropoietin (EPO) enhances circulating level of endothelial progenitor cells (EPCs) which has been reported to be associated with prognostic outcome in ischaemic stroke (IS) patients. This study aimed at evaluating the time course of circulating EPC level and the impact of EPO therapy on EPC level and clinical outcome in patients after acute IS.
Ethics approval(s)
Chang Gung Memorial Hospital Research Ethics Committee, 30/01/2008, ref: 96-1381A
Study design
Prospective randomised placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please contact han.gung@msa.hinet.net to request a patient information sheet
Condition
Acute ischaemic stroke
Intervention
Two consecutive doses of EPO (5,000 IU each time, subcutaneously) administered at 48 hours and 72 hours after acute IS.
Intervention type
Other
Primary outcome measure
90-day combined major adverse neurological event (MANE) defined as:
1. Recurrent stroke
2. National Institutes of Health Stroke Scale (NIHSS) greater than or equal to 8
3. Death
Secondary outcome measures
To establish the time course of circulating level of EPCs in patients after acute IS and the ability of two doses of EPO in enhancing circulating EPC level
Overall study start date
01/10/2008
Overall study end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients aged greater than 45 years, either sex
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
220
Participant exclusion criteria
Patients with history of the followings were excluded from the study:
1. Intracranial haemorrhage
2. Surgery or trauma within the preceding 3 months
3. Abnormal liver function
4. Haematology disorders
5. Renal insufficiency (serum creatinine greater than 1.5 mg/dL)
6. Malignancy
7. Febrile disorders
8. Acute or chronic inflammatory disease at study entry
9. Liver cirrhosis
10. Atrial fibrillation
11. Congestive heart failure
12. Contraindications for magnetic resonance imaging (MRI) examination
13. No evidence of acute IS by MRI study
14. Myeloproliferative disorder
15. Antibodies or being allergic to EPO
16. Pregnancy
17. Haemoglobin level greater than 15.0 g/dL
Recruitment start date
01/10/2008
Recruitment end date
01/03/2010
Locations
Countries of recruitment
Taiwan
Study participating centre
123, Ta Pei Road
Kaohsiung Hsien
83301
Taiwan
Sponsor information
Organisation
National Science Council (Taiwan)
Sponsor details
No. 106
HoPing E. Road
Sec.2
Taipei
10622
Taiwan
Sponsor type
Government
Website
ROR
Funders
Funder type
Government
Funder name
National Science Council (Taiwan) (ref: NSC-97-2314-B-182A-090-MY2)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 25/02/2015 | Yes | No |