Neovascularization Induced by Mechanical Barrier disrUption and Systemic Erythropoietin in Patients With Cerebral Perfusion Deficits

Study Overview
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Brief Summary
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Neovascularization Induced by Mechanical Barrier disrUption and Systemic erythropoietin in patients with cerebral perfusion deficits (NIMBUS trial)

Official Title
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Neovascularization Induced by Mechanical Barrier disrUption and Systemic Erythropoietin in Patients With Cerebral Perfusion Deficits (NIMBUS Trial)

Conditions
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Angiogenesis, Ischemic Stroke

Intervention / Treatment
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* Drug: erythropoietin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 20 85 Acute period (ischemic stroke confirmation on DWI or TIA within 14 days after symptom onset) Below 20 point of initial NIHSS score within 14 days after stroke onset and enrolment. Confirmation of atherosclerotic or steno-occlusive stroke mechanism (proximal cerebral arteries) on CTA or MRA . At least hemodynamically, perfusion status of a candidate is stage II or III (decrease of regional Cerebral blood flow on CBF map), moyamoya disease If female then not of childbearing potential Informed consent Exclusion Criteria: Primary intracerebral haemorrhage (ICH), or parenchymal haemorrhagic transformation of infarction (type PHI or PHII as defined in ECASS), subarachnoid haemorrhage (SAH), arterio-venous malformation (AVM), cerebral aneurysm, or cerebral neoplasm Treated with a thrombolytic <24 hours (if >24 hours and excluded ICH then eligible) Score >=1 on the NIHSS item 1a Pre-stroke mRS score <2 Uncontrolled hypertension(irregularity systollic BP > 150mmHg Previous treatment with erythropoietin At screening: Hemoglobin >14 g/dl, prolonged PT or PTT, serum Cr >2.0 ,mg/dl, BUN >40, thrombocytopenia or neutropenia as defined by the lower limit of normal for the platelet count or white blood cell count, respectively (absolute neutrophil count of > 1800/mm3 required for participation), or > 2 times of normal on liver function tests (SGOT, SGPT, total bilirubin)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>mechanical barrier disruption procedure + hrEPO manufactured by Dong-A pharmaceutics Multiple burrholes with local anesthesia after medication Drug: Erythropoietin 33,000u daily for 3 day via intravenous | Drug: erythropoietin<br> <br> * Other names: eporon;|
| No Intervention: Group B<br>mechanical barrier disruption procedure Drug: no-specific intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful new vascularization of internal-to-external cerebral collateral flow | transdural neovascularization: absent vs. present) from 6- vessel angiography | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Neurological Deterioration (END) during admission | NIHSS scores are daily assessed during admission and neurological deterioration is designated as at least 2-point decrease of NIHSS during 14 days after admission | 14 days | 
| Adverse events during the study period | Overall adverse events (early neurological deterioration; adverse events within 7 days after operation; and adverse events during the study period | up to 6 months |