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

N/AUnknownNCT03882060

Seoul National University Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Moyamoya Disease Pediatrics Cerebrovascular Disorders

Interventions

erythropoietinDRUG

Recombinant human erythropoietin (500 U/kg IVS x 3 times) is administrated to increase the neovascularization after revascularization surgery.

Normal salineDRUG

Control group, no intervention.

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

postoperative <12 month Angiogenesis

Incidence of Good postoperative MCA territory revascularization by cerebral angiography or MRI (3 grade: good, fair, poor)

Time frame: <12 month after revascularization operation

Secondary Outcomes

Short-term postoperative outcome: Incidence and number of the postoperative transient ischemic attack (TIA) within 1 week

Incidence and number of the postoperative transient ischemic attack (TIA) within 1 week (yes or no)

Time frame: up to 1 week

Short-term postoperative outcome: Adverse neurologic event

seizure, increased intracranial pressure, cerebral infarct, hematoma, reoperation (yes or no)

Time frame: within the 1st postoperative hospital stay, up to 1 year

Short-term postoperative outcome: Other postoperative complications

e.g. Circulatory failure/arrest, Respiratory failure/arrest, Infection (yes or no)

Time frame: within the 1st postoperative hospital stay, up to 1 year

Short-term postoperative outcome: ICU stay (days)

ICU stay (discharge criteria: Stable V/S + Consciousness)

Time frame: within the 1st postoperative hospital stay, up to 1 year

Short-term postoperative outcome: Total hospital stay (days)

Total hospital stay (discharge criteria: Stable V/S + no progressive Sx)

Time frame: within the 1st postoperative hospital stay, up to 1 year

Effect of rHuEPO on perioperative erythropoiesis: Total intraoperative and perioperative transfusion requirements (mL/kg)

Data from ClinicalTrials.gov

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