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

Not yet recruiting

Phase 2 Results N/A

Trial Description

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

Conditions

Interventions

  • Erythropoietin Drug
    Other Names: multiple burrhole procedure
    ARM 1: Kind: Experimental
    Label: Group A
    Description: 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

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Successful new vascularization of internal-to-external cerebral collateral flow 6 months No
Secondary Early Neurological Deterioration (END) during admission 14 days Yes
Secondary Adverse events during the study period up to 6 months Yes

Sponsors