ESS: Multicenter Efficacy Study of Recombinant Human Erythropoietin in Acute Ischemic Stroke

Sponsor

Max-Planck-Institute of Experimental Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT00604630

Collaborator

Johnson & Johnson (Industry), Parexel (Industry)

522

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this randomized, double-blind, placebo-controlled multicenter study is to determine in a cohort of 506 patients with acute ischemic stroke in the middle cerebral artery territory, the effect of a three-day high-dose, intravenous erythropoietin treatment on functional outcome up to a follow-up of 90 days.

Condition or Disease	Intervention/Treatment	Phase
Infarction, Middle Cerebral Artery Middle Cerebral Artery Stroke Stroke, Acute	Drug: recombinant human erythropoietin alfa Drug: 0.9% NaCl	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

522 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

German Multicenter EPO Stroke Trial (Phase II/III)

Study Start Date :

Jan 1, 2003

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo 50ml 0.9% NaCL	Drug: 0.9% NaCl 50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms
Active Comparator: verum erythropoietin alfa 40,000 IU iv in 50ml 0.9% NaCl	Drug: recombinant human erythropoietin alfa 40,000 IU in 50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms Other Names: ERYPO

Arm

Intervention/Treatment

Placebo Comparator: placebo

50ml 0.9% NaCL

Drug: 0.9% NaCl

50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms

Active Comparator: verum

erythropoietin alfa 40,000 IU iv in 50ml 0.9% NaCl

Drug: recombinant human erythropoietin alfa

40,000 IU in 50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms

Other Names:

ERYPO

Outcome Measures

Primary Outcome Measures

Neurological/functional outcome as measured by the Barthel Index (BI) [day 90]

Secondary Outcome Measures

Modified Rankin Scale (mRS) responder [day 90]
Barthel Index (BI) [day 30]
mRS [day30, day 90]
NIH Stroke Scale [day 1, 3, 7, 30, 90]
Proportion of subjects with minimal disability (mRS 0-1) [day 30, day 90]
All-cause mortality [day 90]
Mortality directly related to stroke [day 90]
Proportion of subjects with BI >= 95 [day 30, day 90]
Proportion of subjects with BI=100 [day 30, day 90]
Proportion of subjects with neurological recovery [day 3, 7, 30, 90]
Distribution of mRS scores [day 30, day 90]
Distribution of BI scores [day 30, day 90]
Distribution of NIH Stroke Scale scores [day 30, day 90]
Serum level of glial damage markers S100B and GFAP [day 1, 2, 3, 4, 7]
Lesion size (MRI DWI, flair) [day 1, day 7]
Overall survival [day 90]
Late recovery index (BI day 90 versus BI day 30) [day 30 to day 90]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Ischemic stroke in the middle cerebral artery territory
Clearly defined time of onset
Confirmed by MRI (DWI, Flair)
NIH Stroke Scale ≥ 5
Age > 18 years
Treatment within 6h after onset of symptoms
Informed consent by patient, relatives or independent physician
Life expectancy > 90 days

Exclusion Criteria:

Coma or precoma (level of consciousness ≥ 2 in NIH Stroke Scale)
Previous stroke within the same territory
Intracranial or subarachnoidal hemorrhage
Traumatic brain injury or brain operation within the last 4 weeks
Neoplasia, septic embolism, infectious endocarditis
MRI contraindications
Renal failure (i.e. dependent on dialysis)
Known malignant/life-threatening disease
Known myeloproliferative disorder, polycythemia
Known allergy or antibodies against erythropoietin
Participation in other intervention trials
Pregnancy

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Neurologische Klinik des Städtischen Klinikums Braunschweig	Braunschweig	Germany	D-38126
2	Neurologische Klink, Klinikum Bremen-Mitte	Bremen	Germany	D-28177
3	Neurologische Klinik, Allgemeines Krankenhaus Celle	Celle	Germany	D-29223
4	Klinik und Poliklinik für Neurologie, Universitätsklinikum Carl Gustav Carus der TU Dresden	Dresden	Germany	D-01307
5	Neurologische Klinik, Universität Erlangen-Nürnberg	Erlangen	Germany	D-91054
6	Klinik für Neurologie, Universität Essen	Essen	Germany	D-45147
7	Neurologische Universitätsklinik der Georg-August-Universität Goettingen	Goettingen	Germany	D-37075
8	Neurologische Klinik, Medizinische Hochschule Hannover	Hannover	Germany	D-30625
9	Klinik und Poliklinik für Neurologie der Universität Leipzig	Leipzig	Germany	D-04103