NCT03882060进行中（未招募）不适用
The Effect of Recombinant Human Erythropoietin on the Postoperative Neurologic Outcome in Pediatric Moyamoya Disease Patients - A Double Blind Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- postoperative <12 month Angiogenesis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric Moyamoya patients scheduled for the first revascularization surgery
排除标准
- •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)
研究组 & 干预措施
rHuEPO
Experimental
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)
干预措施: erythropoietin (Drug)
Control
Placebo Comparator
Normal saline 50mL x 3 times Preoperative day (12-24 hour before surgery) During surgery Postoperative day (12-24 hour after surgery)
干预措施: Normal saline (Drug)
结局指标
主要结局
postoperative <12 month Angiogenesis
时间窗: <12 month after revascularization operation
Incidence of Good postoperative MCA territory revascularization by cerebral angiography or MRI (3 grade: good, fair, poor)
次要结局
- Preoperative information: Homozygous RNF213(If the preoperative w/u is not completed before recruitment, up to 1 week)
- 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)
- Short-term postoperative outcome: Total hospital stay (days)(within the 1st postoperative hospital stay, up to 1 year)
- Preoperative Cerebral angiography: Suzuki grade, Bilateral involvement(Before up to 1 year)
- Preoperative Hemoglobin, Hematocrit, serum EPO level(If the preoperative w/u is not completed before recruitment, up to 1 week)
- Short-term postoperative outcome: Incidence and number of the postoperative transient ischemic attack (TIA) within 1 week(up to 1 week)
- Short-term postoperative outcome: Adverse neurologic event(within the 1st postoperative hospital stay, up to 1 year)
- Effect of rHuEPO on perioperative erythropoiesis: Total intraoperative and perioperative transfusion requirements (mL/kg)(within the 1st postoperative hospital stay, up to 1 year)
- Long-term neurologic outcome: Clinical outcomes (4 grade): Excellent, Good, Fair, Poor(Outpatient clinical visit, Usually Postoperative 12~18 month, up to 2 years)
- Long-term neurologic outcome: Brain MRI/A or Brain perfusion MRI(Outpatient clinical visit, Usually Postoperative 12~18 month, up to 2 years)
- Short-term postoperative outcome: ICU stay (days)(within the 1st postoperative hospital stay, up to 1 year)
- Effect of rHuEPO on perioperative erythropoiesis: Perioperative Hemoglobin, Hematocrit, serum EPO level(within the 1st postoperative hospital stay, up to 1 year)
- Effect of rHuEPO on perioperative erythropoiesis: GFR, BUN, Creatinine(within the 1st postoperative hospital stay, up to 1 year)
- Short-term postoperative outcome: Other postoperative complications(within the 1st postoperative hospital stay, up to 1 year)
- 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)
- Postoperative <12 month neurologic outcome: Brain Perfusion MRI (2 grade): Favorable, Unfavorable(Outpatient clinical visit, Usually Postoperative 3~6 month, up to 1 year)
- Preoperative Brain MRI/A or Brain Perfusion MRI(If the preoperative w/u is not completed before recruitment, up to 1 week)
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital
研究点 (1)
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