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

Ajou University School of Medicine

Status and phase: Completed; Phase 2

Conditions: Ischemic Stroke; Angiogenesis

Treatments: Drug: erythropoietin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02603406

AJIRB-MED-CT2-15-187-HJM

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups

Group A

Experimental group

Description:

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

Treatment:

Drug: erythropoietin

Group B

No Intervention group

Description:

mechanical barrier disruption procedure Drug: no-specific intervention