Effect of Recombinant Human EPO on the Postoperative Neurologic Outcome in Pediatric Moyamoya Patients
- Conditions
- PediatricsCerebrovascular DisordersMoyamoya Disease
- Interventions
- Drug: Normal saline
- Registration Number
- NCT03882060
- Lead Sponsor
- Seoul National University Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Pediatric Moyamoya patients scheduled for the first revascularization surgery
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Normal saline Normal saline 50mL x 3 times Preoperative day (12-24 hour before surgery) During surgery Postoperative day (12-24 hour after surgery) rHuEPO erythropoietin 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)
- Primary Outcome Measures
Name Time Method postoperative <12 month Angiogenesis <12 month after revascularization operation Incidence of Good postoperative MCA territory revascularization by cerebral angiography or MRI (3 grade: good, fair, poor)
- Secondary Outcome Measures
Name Time Method Preoperative information: Homozygous RNF213 If the preoperative w/u is not completed before recruitment, up to 1 week Homozygous RNF213
Long-term neurologic outcome: Cognitive function assessed by Korean Wechsler Intelligence Scale for Children-Ⅳ (K-WISC-Ⅳ) Outpatient clinical visit, Usually Postoperative 12~18 month, up to 2 years Cognitive function assessed by Korean Wechsler Intelligence Scale for Children-Ⅳ (K-WISC-Ⅳ, has 4 domaines: Verbal Comprehension Index, Perceptual Reasoning Index, Working Memory Index, Processing Speed Index \> final score is calculated from T-score)
Short-term postoperative outcome: Total hospital stay (days) within the 1st postoperative hospital stay, up to 1 year Total hospital stay (discharge criteria: Stable V/S + no progressive Sx)
Preoperative Cerebral angiography: Suzuki grade, Bilateral involvement Before up to 1 year Cerebral angiography: Suzuki grade(1-6), Bilateral involvement (yes/no)
Preoperative Hemoglobin, Hematocrit, serum EPO level If the preoperative w/u is not completed before recruitment, up to 1 week Preoperative Hemoglobin, Hematocrit, serum EPO level
Short-term postoperative outcome: Incidence and number of the postoperative transient ischemic attack (TIA) within 1 week up to 1 week Incidence and number of the postoperative transient ischemic attack (TIA) within 1 week (yes or no)
Short-term postoperative outcome: Adverse neurologic event within the 1st postoperative hospital stay, up to 1 year seizure, increased intracranial pressure, cerebral infarct, hematoma, reoperation (yes or no)
Effect of rHuEPO on perioperative erythropoiesis: Total intraoperative and perioperative transfusion requirements (mL/kg) within the 1st postoperative hospital stay, up to 1 year Total intraoperative and perioperative transfusion requirements (mL/kg)
Long-term neurologic outcome: Clinical outcomes (4 grade): Excellent, Good, Fair, Poor Outpatient clinical visit, Usually Postoperative 12~18 month, up to 2 years Clinical outcomes (4 grade): Excellent, Good, Fair, Poor
Long-term neurologic outcome: Brain MRI/A or Brain perfusion MRI Outpatient clinical visit, Usually Postoperative 12~18 month, up to 2 years Brain MRI/A or Brain perfusion MRI (2 grade): Favorable, Unfavorable
Short-term postoperative outcome: ICU stay (days) within the 1st postoperative hospital stay, up to 1 year ICU stay (discharge criteria: Stable V/S + Consciousness)
Effect of rHuEPO on perioperative erythropoiesis: Perioperative Hemoglobin, Hematocrit, serum EPO level within the 1st postoperative hospital stay, up to 1 year Perioperative Hemoglobin, Hematocrit, serum EPO level
Effect of rHuEPO on perioperative erythropoiesis: GFR, BUN, Creatinine within the 1st postoperative hospital stay, up to 1 year GFR, BUN, Creatinine level
Short-term postoperative outcome: Other postoperative complications within the 1st postoperative hospital stay, up to 1 year e.g. Circulatory failure/arrest, Respiratory failure/arrest, Infection (yes or no)
Postoperative <12 month neurologic outcome: Clinical outcomes (4 grade): Excellent, Good, Fair, Poor Outpatient clinical visit, Usually Postoperative 3~6 month, up to 1 year Clinical outcomes (4 grade): Excellent, Good, Fair, Poor
Postoperative <12 month neurologic outcome: Brain Perfusion MRI (2 grade): Favorable, Unfavorable Outpatient clinical visit, Usually Postoperative 3~6 month, up to 1 year Brain Perfusion MRI (2 grade): Favorable, Unfavorable
Preoperative Brain MRI/A or Brain Perfusion MRI If the preoperative w/u is not completed before recruitment, up to 1 week Brain MRI/A or Brain Perfusion MRI (2 grade): Favorable, Unfavorable
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of