Cerebrovascular Disorders, Moyamoya Disease, Pediatrics
Conditions
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.
Interventions
DRUGerythropoietin
Recombinant human erythropoietin (500 U/kg IVS x 3 times) is administrated to increase the neovascularization after revascularization surgery.
DRUGNormal saline
Control group, no intervention.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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 |
| 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 |
| 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) |
| 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 |
| 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) |
| Preoperative Cerebral angiography: Suzuki grade, Bilateral involvement | Before up to 1 year | Cerebral angiography: Suzuki grade(1-6), Bilateral involvement (yes/no) |
| 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 |
| 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 |
| Preoperative information: Homozygous RNF213 | If the preoperative w/u is not completed before recruitment, up to 1 week | Homozygous RNF213 |
| 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 |
Countries
South Korea
Outcome results
None listed