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

August 17, 2020 updated by: Ji Man Hong, Ajou University School of Medicine

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful new vascularization of internal-to-external cerebral collateral flow
Time Frame: 6 months
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
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
14 days
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
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Collaborators

Dong-A Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2016

Primary Completion (Actual)

July 16, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

November 10, 2015

First Submitted That Met QC Criteria

November 10, 2015

First Posted (Estimate)

November 11, 2015

Study Record Updates

Last Update Posted (Actual)

August 19, 2020

Last Update Submitted That Met QC Criteria

August 17, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-MED-CT2-15-187-HJM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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