Erythropoeitin to facilitate stroke recovery

Not Applicable

Completed

Conditions: Stroke
Circulatory System
Stroke, not specified as haemorrhage or infarction

Registration Number: ISRCTN50896492

Lead Sponsor: King's College Hospital NHS Foundation Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 90

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

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