Effect of erythropoietin on level of circulating endothelial progenitor cells and outcome in patients after acute ischaemic stroke
| ISRCTN | ISRCTN71371114 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71371114 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/11/2010
- Registration date
- 10/01/2011
- Last edited
- 14/01/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Hon-Kan Yip
Scientific
Scientific
123, Ta Pei Road
Niao Sung Hsiang
Kaohsiung Hsien
83301
Taiwan
Study information
| Study design | Prospective randomised placebo-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 han.gung@msa.hinet.net to request a patient information sheet |
| 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 |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 220 |
| Key inclusion criteria | Patients aged greater than 45 years, either sex |
| Key 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 |
| Date of first enrolment | 01/10/2008 |
| Date of final enrolment | 01/03/2010 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
123, Ta Pei Road
Kaohsiung Hsien
83301
Taiwan
83301
Taiwan
Sponsor information
National Science Council (Taiwan)
Government
Government
No. 106, HoPing E. Road
Sec.2
Taipei
10622
Taiwan
| Website | http://web.nsc.gov.tw/ |
|---|---|
"ROR" |
https://ror.org/02kv4zf79 |
Funders
Funder type
Government
National Science Council (Taiwan) (ref: NSC-97-2314-B-182A-090-MY2)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 25/02/2015 | Yes | No |
Editorial Notes
14/01/2016: Publication reference added.
