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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02603406
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : August 19, 2020
Dong-A Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Ji Man Hong, Ajou University School of Medicine

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

Condition or disease Intervention/treatment Phase
Angiogenesis Ischemic Stroke Drug: erythropoietin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Neovascularization Induced by Mechanical Barrier disrUption and Systemic Erythropoietin in Patients With Cerebral Perfusion Deficits (NIMBUS Trial)
Actual Study Start Date : July 15, 2016
Actual Primary Completion Date : July 16, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Group A
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
Other Name: eporon

No Intervention: Group B
mechanical barrier disruption procedure Drug: no-specific intervention

Primary Outcome Measures :
  1. Successful new vascularization of internal-to-external cerebral collateral flow [ Time Frame: 6 months ]
    transdural neovascularization: absent vs. present) from 6- vessel angiography

Secondary Outcome Measures :
  1. Early Neurological Deterioration (END) during admission [ Time Frame: 14 days ]
    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

  2. Adverse events during the study period [ Time Frame: up to 6 months ]
    Overall adverse events (early neurological deterioration; adverse events within 7 days after operation; and adverse events during the study period

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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Responsible Party: Ji Man Hong, Associate professor, Ajou University School of Medicine Identifier: NCT02603406    
Other Study ID Numbers: AJIRB-MED-CT2-15-187-HJM
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Neovascularization, Pathologic
Pathologic Processes
Epoetin Alfa