Clincosm LogoSign in Get a demo

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

Sponsor
Ajou University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT02603406
Collaborator
Dong-A Pharmaceutical Co., Ltd. (Industry)
44
Enrollment
2
Arms
41.5
Actual Duration (Months)

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Jul 15, 2016
Actual Primary Completion Date :
Jul 16, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

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 Names:
  • eporon

    		•
    No Intervention: Group B

    mechanical barrier disruption procedure Drug: no-specific intervention

    Outcome Measures

    Primary Outcome Measures

    1. Successful new vascularization of internal-to-external cerebral collateral flow [6 months]

      transdural neovascularization: absent vs. present) from 6- vessel angiography

    Secondary Outcome Measures

    1. Early Neurological Deterioration (END) during admission [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 [up to 6 months]

      Overall adverse events (early neurological deterioration; adverse events within 7 days after operation; and adverse events during the study period

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 85 Years
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ajou University School of Medicine
    • Dong-A Pharmaceutical Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    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:
    Nov 11, 2015
    Last Update Posted:
    Aug 19, 2020
    Last Verified:
    Aug 1, 2020
    Additional relevant MeSH terms:
    Ischemic Stroke
    Neovascularization, Pathologic
    Epoetin Alfa

    Study Results

    No Results Posted as of Aug 19, 2020