Condition category
Circulatory System
Date applied
23/11/2010
Date assigned
10/01/2011
Last edited
14/01/2016
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

Dr Hon-Kan Yip

ORCID ID

Contact details

123
Ta Pei Road
Niao Sung Hsiang
Kaohsiung Hsien
83301
Taiwan

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

01/10/2008

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Patients aged greater than 45 years, either sex

Participant type

Patient

Age group

Adult

Gender

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

Trial 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

http://web.nsc.gov.tw/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25888250

Publication citations

Additional files

Editorial Notes

14/01/2016: Publication reference added.