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

Seoul National University

Status: Active, not recruiting

Conditions: Pediatrics; Moyamoya Disease; Cerebrovascular Disorders

Treatments: Drug: Normal saline; Drug: erythropoietin

Study type: Interventional

Funder types: Other

Identifiers

NCT03882060

H-1812-165-999

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

rHuEPO

Experimental group

Description:

recombinant human erythropoietin 500 U/kg IVS x 3 times Preoperative day (12-24 hour before surgery) During surgery Postoperative day (12-24 hour after surgery)

Treatment:

Drug: erythropoietin

Control

Placebo Comparator group

Description:

Normal saline 50mL x 3 times Preoperative day (12-24 hour before surgery) During surgery Postoperative day (12-24 hour after surgery)

Treatment:

Drug: Normal saline