Condition category
Circulatory System
Date applied
20/09/2012
Date assigned
27/11/2012
Last edited
27/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Background and study aims
Stroke affects nearly 100,000 people in the UK every year, and only half of all stroke survivors make a full recovery. Rehabilitation leads to improvements in many cases, but it is possible that other treatments can improve recovery even further. One such treatment is Erythropoietin (EPO), which is a purified artificially produced hormone that stimulates the growth of stem cells, especially in the bone marrow, which leads to an increase in the production of red blood cells. It also stimulates the growth of other stem cells involved in repair and some studies have suggested that it may increase brain repair in patients who have suffered stroke. EPO has been used routinely for several years to treat anaemia. The aim of this study is to find out if treatment with EPO, together with rehabilitation further improves recovery.

Who can participate?
Men and women aged between 18 and 85 years who are approached to take part within 48 hours of having a stroke, and do not already have a significant disability.

What does the study involve?
Eligible patients undergo a comprehensive MR imaging for blood flow, concentration of different chemicals and connections across the brain. Following this, patients are randomly allocated to one of three groups. The control group receive standard of care treatment with therapists and the rehabilitation team. The second group receive the drug erythropoietin (EPO) on three occasions injected into the vein on days 1, 3 and 5. The third group receive the drug rhEPO injected into the vein on days 7, 14 and 21. Patients are monitored for 1 week after the treatment with clinical examination and blood tests. The EPO injection is not given if blood tests show too much blood is being produced. Further analyses are made 30 and 90 days after being included in the study. A further MRI scan of the head is done to assess recovery.

What are the possible benefits and risks of participating?
A possible individual benefit of being treated with EPO cannot be stated at this point in time but the results of the study will contribute to a better public knowledge about the best treatment for rehabilitation after a stroke. Like most drugs, EPO could cause some side effects or an allergic reaction. The most common side effects include a rise in blood pressure, headache, nausea and joint pains which occur in about 1 in 10 patients especially at the start of treatment. About 1 in 100 patients show an increase in the number of platelets that can increase the risk of clots. Other side effects include diarrhoea, flu-like illness, rash, and vomiting which may occur in 1-2 in 100 patients. Allergic reactions are rare and include rash, itching, and very rarely swelling of the tongue and mouth.

Where is the study run from?
The study is run from King’s College Hospital NHS Foundation Trust and the Department of Clinical Neurosciences, King’s College London (UK)

When is the study starting and how long is it expected to run for?
November 2012 to May 2014

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Prof. Lalit Kalra
lalit.kalra@kcl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Lalit Kalra

ORCID ID

Contact details

King's College Hospital NHS Trust
Bessemer Road
London
SE5 9PJ
United Kingdom
-
lalit.kalra@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10503

Study information

Scientific title

Erythropoeitin to facilitate stroke recovery: a randomised trial

Acronym

Study hypothesis

The research will show whether EPO treatment given early or late during stroke recovery has the potential to improve recovery in stroke patients who have not been thrombolysed. If EPO is shown to have the potential to influence brain repair, information from the study will be used to design larger definitive clinical trials for translation into clinical use in 35 years.

Ethics approval

NRES Committee London - Westminster, 26/05/2011, ref:11/LO/0346

Study design

Randomised 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 use the contact details to request a patient information sheet

Condition

Stroke

Intervention

The research will be undertaken in three groups of 30 stroke patients each who are within 48 hours of stroke onset, have not been thrombolysed and have no contraindications to EPO treatment. All groups will receive best usual treatment consisting of structured multidisciplinary rehabilitation on a stroke unit. In addition, participants in the second group will receive EPO 40,000 IU given intravenously at 1, 3 and 5 days and those in the third group will receive EPO 40,000 IU/ given intravenously at 7, 14, 21 days. The differences in recovery between the groups will be assessed at 30 and 90 days after randomisation by measuring clinical recovery in function and changes in the brain perfusion and structure using magnetic resonance (MR) imaging.

Intervention type

Drug

Phase

Not Applicable

Drug names

Erythropoeitin

Primary outcome measures

Change in Fugl-Meyer scale score from baseline

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/11/2012

Overall trial end date

31/05/2014

Reason abandoned

Difficulties in recruitment and withdrawal of funding

Eligibility

Participant inclusion criteria

1. Supratentorial ischaemic stroke, confirmed on imaging
2. Recruited within 48 hours of stroke onset. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when patient was last seen or was selfreported to be normal
3. NIHSS score 624 with NIHSS 1A (level of consciousness) score <2 at the time of enrolment
4. Reasonable expectation of availability to receive the full course of therapy, and to be available for subsequent follow-up visits
5. Reasonable expectation that patient will receive standard poststroke physical, occupational and speech therapy as indicated

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 90

Participant exclusion criteria

1. Prestroke modified Rankin Score (mRS) >2
2. Thrombolytic treatment with tPA following the index stroke
3. Patients presenting with hemorrhagic and/or brain stem stroke
4. Women who may be pregnant or breastfeeding
5. Serum hemoglobin > 16 g/dL (males) or > 14 g/dL (females), or platelet count > 400,000/mm3
6. Advanced liver, kidney, cardiac or pulmonary disease (serum bilirubin > 1.5 x upper limit of normal (ULN), Alkaline phosphatase > 2.5 x ULN, GGT>2.5xULN
7. History of clotting disorders
8. Expected survival < 1 year
9. Allergy or other contraindication to erythropoeitin as per SPMC
10. A known diagnosis of cancer (except nonmalignant skin cancer)
11. A known diagnosis of epilepsy
12. Uncontrolled hypertension (BP persistently > 220 mm Hg systolic or 120 mm Hg diastolic despite antihypertensive therapy)
13. Preexisting and active major psychiatric or other chronic neurological disease
14. Currently participating in another investigational study

Recruitment start date

01/11/2012

Recruitment end date

31/05/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College Hospital NHS Trust
London
SE5 9PJ
United Kingdom

Sponsor information

Organisation

King's College Hospital NHS Foundation Trust (UK)

Sponsor details

Neonatal intensive care unit (NICU)
Denmark Hill
London
SE5 9RS
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.kch.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) - Central Commissioning Facility (UK)

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

27/01/2017: The trial was stopped prematurely because of difficulties in recruitment and withdrawal of funding. There are no publications related to the trial.