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Effect of Recombinant Human EPO on the Postoperative Neurologic Outcome in Pediatric Moyamoya Patients

South Korea60 participantsStarted 2019-04-08

Plain-language summary

This study evaluates the effect of recombinant human erythropoietin (rHuEPO) on the neovascularization of pediatric moyamoya disease patients. rHuEPO will be administrated during perioperative period of the first revascularization surgery. Primary outcome (Incidence of Good postoperative MCA territory revascularization by cerebral angiography) will be evaluated after 3-6 month of revascularization surgery.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Pediatric Moyamoya patients scheduled for the first revascularization surgery Exclusion Criteria: * Hypersensitivity or contraindication to rHuEPO * History of Unstable hypertension, Hypertensive encephalopathy, Thrombosis * Primary intracerebral hemorrhage (ICH), Subarachnoid hemorrhage (SAH), Arterio-venous malformation (AVM), Cerebral aneurysm, or cerebral neoplasm * History of seizure * Hemoglobin \>16 mg/dl * Prolonged PT (PT \> 15.5 seconds, PT INR \> 1.2) or Prolonged aPTT (\> 40 seconds) * Thrombocytopenia (platelet count \< 100,000/microL), Thrombocytosis (platelet count \> 400,000/microL), Neutropenia (absolute neutrophil count (ANC) \< 1500/microL) * Abnormal kidney function (Creatinine\> 2.0 mg/dl, History of dialysis) * Abnormal hepatic function (aspartate transaminase\> 80 unit/L, alanine aminotransferase\> 80 unit/L)

What they're measuring

postoperative <12 month Angiogenesis

Timeframe: <12 month after revascularization operation

Trial details

NCT IDNCT03882060

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More Moyamoya Disease trials