Back to resultsEffect of Recombinant Human EPO on the Postoperative Neurologic Outcome in Pediatric Moyamoya Patients
Primary Purpose
Moyamoya Disease, Pediatrics, Cerebrovascular Disorders
Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
erythropoietin
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Moyamoya Disease
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)
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
rHuEPO
Control
Arm Description
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)
Normal saline 50mL x 3 times Preoperative day (12-24 hour before surgery) During surgery Postoperative day (12-24 hour after surgery)
Outcomes
Primary Outcome Measures
postoperative <12 month Angiogenesis
Incidence of Good postoperative MCA territory revascularization by cerebral angiography or MRI (3 grade: good, fair, poor)
Secondary Outcome Measures
Short-term postoperative outcome: Incidence and number of the postoperative transient ischemic attack (TIA) within 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
seizure, increased intracranial pressure, cerebral infarct, hematoma, reoperation (yes or no)
Short-term postoperative outcome: Other postoperative complications
e.g. Circulatory failure/arrest, Respiratory failure/arrest, Infection (yes or no)
Short-term postoperative outcome: ICU stay (days)
ICU stay (discharge criteria: Stable V/S + Consciousness)
Short-term postoperative outcome: Total hospital stay (days)
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)
Total intraoperative and perioperative transfusion requirements (mL/kg)
Effect of rHuEPO on perioperative erythropoiesis: Perioperative Hemoglobin, Hematocrit, serum EPO level
Perioperative Hemoglobin, Hematocrit, serum EPO level
Effect of rHuEPO on perioperative erythropoiesis: GFR, BUN, Creatinine
GFR, BUN, Creatinine level
Postoperative <12 month neurologic outcome: Clinical outcomes (4 grade): Excellent, Good, Fair, Poor
Clinical outcomes (4 grade): Excellent, Good, Fair, Poor
Postoperative <12 month neurologic outcome: Brain Perfusion MRI (2 grade): Favorable, Unfavorable
Brain Perfusion MRI (2 grade): Favorable, Unfavorable
Long-term neurologic outcome: Clinical outcomes (4 grade): Excellent, Good, Fair, Poor
Clinical outcomes (4 grade): Excellent, Good, Fair, Poor
Long-term neurologic outcome: Brain MRI/A or Brain perfusion MRI
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)
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
Cerebral angiography: Suzuki grade(1-6), Bilateral involvement (yes/no)
Preoperative Brain MRI/A or Brain Perfusion MRI
Brain MRI/A or Brain Perfusion MRI (2 grade): Favorable, Unfavorable
Preoperative Hemoglobin, Hematocrit, serum EPO level
Preoperative Hemoglobin, Hematocrit, serum EPO level
Preoperative information: Homozygous RNF213
Homozygous RNF213
Full Information
NCT ID
NCT03882060
First Posted
March 12, 2019
Last Updated
June 2, 2022
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03882060
Brief Title
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 8, 2019 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moyamoya Disease, Pediatrics, Cerebrovascular Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rHuEPO
Arm Type
Experimental
Arm Description
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)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Normal saline 50mL x 3 times Preoperative day (12-24 hour before surgery) During surgery Postoperative day (12-24 hour after surgery)
Intervention Type
Drug
Intervention Name(s)
erythropoietin
Other Intervention Name(s)
rHuEPO
Intervention Description
Recombinant human erythropoietin (500 U/kg IVS x 3 times) is administrated to increase the neovascularization after revascularization surgery.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Control
Intervention Description
Control group, no intervention.
Primary Outcome Measure Information:
Title
postoperative <12 month Angiogenesis
Description
Incidence of Good postoperative MCA territory revascularization by cerebral angiography or MRI (3 grade: good, fair, poor)
Time Frame
<12 month after revascularization operation
Secondary Outcome Measure Information:
Title
Short-term postoperative outcome: Incidence and number of the postoperative transient ischemic attack (TIA) within 1 week
Description
Incidence and number of the postoperative transient ischemic attack (TIA) within 1 week (yes or no)
Time Frame
up to 1 week
Title
Short-term postoperative outcome: Adverse neurologic event
Description
seizure, increased intracranial pressure, cerebral infarct, hematoma, reoperation (yes or no)
Time Frame
within the 1st postoperative hospital stay, up to 1 year
Title
Short-term postoperative outcome: Other postoperative complications
Description
e.g. Circulatory failure/arrest, Respiratory failure/arrest, Infection (yes or no)
Time Frame
within the 1st postoperative hospital stay, up to 1 year
Title
Short-term postoperative outcome: ICU stay (days)
Description
ICU stay (discharge criteria: Stable V/S + Consciousness)
Time Frame
within the 1st postoperative hospital stay, up to 1 year
Title
Short-term postoperative outcome: Total hospital stay (days)
Description
Total hospital stay (discharge criteria: Stable V/S + no progressive Sx)
Time Frame
within the 1st postoperative hospital stay, up to 1 year
Title
Effect of rHuEPO on perioperative erythropoiesis: Total intraoperative and perioperative transfusion requirements (mL/kg)
Description
Total intraoperative and perioperative transfusion requirements (mL/kg)
Time Frame
within the 1st postoperative hospital stay, up to 1 year
Title
Effect of rHuEPO on perioperative erythropoiesis: Perioperative Hemoglobin, Hematocrit, serum EPO level
Description
Perioperative Hemoglobin, Hematocrit, serum EPO level
Time Frame
within the 1st postoperative hospital stay, up to 1 year
Title
Effect of rHuEPO on perioperative erythropoiesis: GFR, BUN, Creatinine
Description
GFR, BUN, Creatinine level
Time Frame
within the 1st postoperative hospital stay, up to 1 year
Title
Postoperative <12 month neurologic outcome: Clinical outcomes (4 grade): Excellent, Good, Fair, Poor
Description
Clinical outcomes (4 grade): Excellent, Good, Fair, Poor
Time Frame
Outpatient clinical visit, Usually Postoperative 3~6 month, up to 1 year
Title
Postoperative <12 month neurologic outcome: Brain Perfusion MRI (2 grade): Favorable, Unfavorable
Description
Brain Perfusion MRI (2 grade): Favorable, Unfavorable
Time Frame
Outpatient clinical visit, Usually Postoperative 3~6 month, up to 1 year
Title
Long-term neurologic outcome: Clinical outcomes (4 grade): Excellent, Good, Fair, Poor
Description
Clinical outcomes (4 grade): Excellent, Good, Fair, Poor
Time Frame
Outpatient clinical visit, Usually Postoperative 12~18 month, up to 2 years
Title
Long-term neurologic outcome: Brain MRI/A or Brain perfusion MRI
Description
Brain MRI/A or Brain perfusion MRI (2 grade): Favorable, Unfavorable
Time Frame
Outpatient clinical visit, Usually Postoperative 12~18 month, up to 2 years
Title
Long-term neurologic outcome: Cognitive function assessed by Korean Wechsler Intelligence Scale for Children-Ⅳ (K-WISC-Ⅳ)
Description
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)
Time Frame
Outpatient clinical visit, Usually Postoperative 12~18 month, up to 2 years
Title
Preoperative Cerebral angiography: Suzuki grade, Bilateral involvement
Description
Cerebral angiography: Suzuki grade(1-6), Bilateral involvement (yes/no)
Time Frame
Before up to 1 year
Title
Preoperative Brain MRI/A or Brain Perfusion MRI
Description
Brain MRI/A or Brain Perfusion MRI (2 grade): Favorable, Unfavorable
Time Frame
If the preoperative w/u is not completed before recruitment, up to 1 week
Title
Preoperative Hemoglobin, Hematocrit, serum EPO level
Description
Preoperative Hemoglobin, Hematocrit, serum EPO level
Time Frame
If the preoperative w/u is not completed before recruitment, up to 1 week
Title
Preoperative information: Homozygous RNF213
Description
Homozygous RNF213
Time Frame
If the preoperative w/u is not completed before recruitment, up to 1 week
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Recombinant Human EPO on the Postoperative Neurologic Outcome in Pediatric Moyamoya Patients
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