Clinical trial NCT03882060: Effect of Recombinant Human EPO on the Postoperative Neurologic Outcome in Pediatric Moyamoya Patients
Official title: The Effect of Recombinant Human Erythropoietin on the Postoperative Neurologic Outcome in Pediatric Moyamoya Disease Patients - A Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Moyamoya Disease
Pediatrics
Cerebrovascular Disorders
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 60
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: postoperative <12 month Angiogenesis
timeFrame: <12 month after revascularization operation
Secondary outcomes:
measure: Short-term postoperative outcome: Incidence and number of the postoperative transient ischemic attack (TIA) within 1 week
timeFrame: up to 1 week
measure: Short-term postoperative outcome: Adverse neurologic event
timeFrame: within the 1st postoperative hospital stay, up to 1 year
measure: Short-term postoperative outcome: Other postoperative complications
timeFrame: within the 1st postoperative hospital stay, up to 1 year
measure: Short-term postoperative outcome: ICU stay (days)
timeFrame: within the 1st postoperative hospital stay, up to 1 year
measure: Short-term postoperative outcome: Total hospital stay (days)
timeFrame: within the 1st postoperative hospital stay, up to 1 year
measure: Effect of rHuEPO on perioperative erythropoiesis: Total intraoperative and perioperative transfusion requirements (mL/kg)
timeFrame: within the 1st postoperative hospital stay, up to 1 year
measure: Effect of rHuEPO on perioperative erythropoiesis: Perioperative Hemoglobin, Hematocrit, serum EPO level
timeFrame: within the 1st postoperative hospital stay, up to 1 year
measure: Effect of rHuEPO on perioperative erythropoiesis: GFR, BUN, Creatinine
timeFrame: within the 1st postoperative hospital stay, up to 1 year
measure: Postoperative <12 month neurologic outcome: Clinical outcomes (4 grade): Excellent, Good, Fair, Poor
timeFrame: Outpatient clinical visit, Usually Postoperative 3~6 month, up to 1 year
measure: Postoperative <12 month neurologic outcome: Brain Perfusion MRI (2 grade): Favorable, Unfavorable
timeFrame: Outpatient clinical visit, Usually Postoperative 3~6 month, up to 1 year
measure: Long-term neurologic outcome: Clinical outcomes (4 grade): Excellent, Good, Fair, Poor
timeFrame: Outpatient clinical visit, Usually Postoperative 12~18 month, up to 2 years
measure: Long-term neurologic outcome: Brain MRI/A or Brain perfusion MRI
timeFrame: Outpatient clinical visit, Usually Postoperative 12~18 month, up to 2 years
measure: Long-term neurologic outcome: Cognitive function assessed by Korean Wechsler Intelligence Scale for Children-Ⅳ (K-WISC-Ⅳ)
timeFrame: Outpatient clinical visit, Usually Postoperative 12~18 month, up to 2 years
measure: Preoperative Cerebral angiography: Suzuki grade, Bilateral involvement
timeFrame: Before up to 1 year
measure: Preoperative Brain MRI/A or Brain Perfusion MRI
timeFrame: If the preoperative w/u is not completed before recruitment, up to 1 week
measure: Preoperative Hemoglobin, Hematocrit, serum EPO level
timeFrame: If the preoperative w/u is not completed before recruitment, up to 1 week
measure: Preoperative information: Homozygous RNF213
timeFrame: If the preoperative w/u is not completed before recruitment, up to 1 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
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