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

NCT02603406 | Completed Phase 2

• 1 other identifier: AJIRB-MED-CT2-15-187-HJM
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Angiogenesis; Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Successful new vascularization of internal-to-external cerebral collateral flow

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

  6 months

Secondary Outcomes (2)

• Early Neurological Deterioration (END) during admission

  14 days

• Adverse events during the study period

  up to 6 months

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

NO INTERVENTION

mechanical barrier disruption procedure Drug: no-specific intervention

Interventions

erythropoietin DRUG

Also known as: eporon

Group A

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Related Publications (27)

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  PMID: 35579016 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Erythropoietin

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 11, 2015
• Study Start: July 15, 2016
• Primary Completion: July 16, 2019
• Study Completion: December 31, 2019
• Last Updated: August 19, 2020

Record last verified: 2020-08