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Register:	ClinicalTrials.gov
Last refreshed on:	4 December 2023
Main ID:	NCT03882060
Date of registration:	12/03/2019
Prospective Registration:	Yes
Primary sponsor:	Seoul National University Hospital
Public title:	Effect of Recombinant Human EPO on the Postoperative Neurologic Outcome in Pediatric Moyamoya Patients
Scientific title:	The Effect of Recombinant Human Erythropoietin on the Postoperative Neurologic Outcome in Pediatric Moyamoya Disease Patients - A Double Blind Randomized Controlled Trial
Date of first enrolment:	April 8, 2019
Target sample size:	60
Recruitment status:	Active, not recruiting
URL:	https://clinicaltrials.gov/ct2/show/NCT03882060
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
Phase:	N/A

Countries of recruitment
Korea, Republic of

Contacts

Key inclusion & exclusion 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)

Age minimum: N/A
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pediatrics

Cerebrovascular Disorders

Moyamoya Disease

Intervention(s)

Drug: erythropoietin

Drug: Normal saline

Primary Outcome(s)

postoperative <12 month Angiogenesis [Time Frame: <12 month after revascularization operation]

Secondary Outcome(s)

Short-term postoperative outcome: ICU stay (days) [Time Frame: within the 1st postoperative hospital stay, up to 1 year]

Effect of rHuEPO on perioperative erythropoiesis: GFR, BUN, Creatinine [Time Frame: within the 1st postoperative hospital stay, up to 1 year]

Preoperative Brain MRI/A or Brain Perfusion MRI [Time Frame: If the preoperative w/u is not completed before recruitment, up to 1 week]

Postoperative <12 month neurologic outcome: Brain Perfusion MRI (2 grade): Favorable, Unfavorable [Time Frame: Outpatient clinical visit, Usually Postoperative 3~6 month, up to 1 year]

Preoperative Hemoglobin, Hematocrit, serum EPO level [Time Frame: If the preoperative w/u is not completed before recruitment, up to 1 week]

Short-term postoperative outcome: Other postoperative complications [Time Frame: within the 1st postoperative hospital stay, up to 1 year]

Effect of rHuEPO on perioperative erythropoiesis: Total intraoperative and perioperative transfusion requirements (mL/kg) [Time Frame: within the 1st postoperative hospital stay, up to 1 year]

Preoperative Cerebral angiography: Suzuki grade, Bilateral involvement [Time Frame: Before up to 1 year]

Short-term postoperative outcome: Adverse neurologic event [Time Frame: within the 1st postoperative hospital stay, up to 1 year]

Effect of rHuEPO on perioperative erythropoiesis: Perioperative Hemoglobin, Hematocrit, serum EPO level [Time Frame: within the 1st postoperative hospital stay, up to 1 year]

Preoperative information: Homozygous RNF213 [Time Frame: If the preoperative w/u is not completed before recruitment, up to 1 week]

Long-term neurologic outcome: Brain MRI/A or Brain perfusion MRI [Time Frame: Outpatient clinical visit, Usually Postoperative 12~18 month, up to 2 years]

Short-term postoperative outcome: Total hospital stay (days) [Time Frame: within the 1st postoperative hospital stay, up to 1 year]

Long-term neurologic outcome: Cognitive function assessed by Korean Wechsler Intelligence Scale for Children-? (K-WISC-?) [Time Frame: Outpatient clinical visit, Usually Postoperative 12~18 month, up to 2 years]

Postoperative <12 month neurologic outcome: Clinical outcomes (4 grade): Excellent, Good, Fair, Poor [Time Frame: Outpatient clinical visit, Usually Postoperative 3~6 month, up to 1 year]

Long-term neurologic outcome: Clinical outcomes (4 grade): Excellent, Good, Fair, Poor [Time Frame: Outpatient clinical visit, Usually Postoperative 12~18 month, up to 2 years]

Short-term postoperative outcome: Incidence and number of the postoperative transient ischemic attack (TIA) within 1 week [Time Frame: up to 1 week]

Secondary ID(s)

H-1812-165-999

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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