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

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ClinicalTrials.gov Identifier: NCT02603406
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : August 19, 2020
Sponsor:
Collaborator:
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
Criteria

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)
Publications:

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Responsible Party: Ji Man Hong, Associate professor, Ajou University School of Medicine
ClinicalTrials.gov 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
Metaplasia
Pathologic Processes
Epoetin Alfa
Hematinics