Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-03-03 @ 4:12 PM
Study NCT ID:
NCT03882060
Status:
UNKNOWN
Last Update Posted:
2023-11-22
First Post:
2019-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Recombinant Human EPO on the Postoperative Neurologic Outcome in Pediatric Moyamoya Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009072', 'term': 'Moyamoya Disease'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002539', 'term': 'Cerebral Arterial Diseases'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-21', 'studyFirstSubmitDate': '2019-03-12', 'studyFirstSubmitQcDate': '2019-03-16', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative <12 month Angiogenesis', 'timeFrame': '<12 month after revascularization operation', 'description': 'Incidence of Good postoperative MCA territory revascularization by cerebral angiography or MRI (3 grade: good, fair, poor)'}], 'secondaryOutcomes': [{'measure': 'Short-term postoperative outcome: Incidence and number of the postoperative transient ischemic attack (TIA) within 1 week', 'timeFrame': 'up to 1 week', 'description': 'Incidence and number of the postoperative transient ischemic attack (TIA) within 1 week (yes or no)'}, {'measure': 'Short-term postoperative outcome: Adverse neurologic event', 'timeFrame': 'within the 1st postoperative hospital stay, up to 1 year', 'description': 'seizure, increased intracranial pressure, cerebral infarct, hematoma, reoperation (yes or no)'}, {'measure': 'Short-term postoperative outcome: Other postoperative complications', 'timeFrame': 'within the 1st postoperative hospital stay, up to 1 year', 'description': 'e.g. Circulatory failure/arrest, Respiratory failure/arrest, Infection (yes or no)'}, {'measure': 'Short-term postoperative outcome: ICU stay (days)', 'timeFrame': 'within the 1st postoperative hospital stay, up to 1 year', 'description': 'ICU stay (discharge criteria: Stable V/S + Consciousness)'}, {'measure': 'Short-term postoperative outcome: Total hospital stay (days)', 'timeFrame': 'within the 1st postoperative hospital stay, up to 1 year', 'description': 'Total hospital stay (discharge criteria: Stable V/S + no progressive Sx)'}, {'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', 'description': 'Total intraoperative and perioperative transfusion requirements (mL/kg)'}, {'measure': 'Effect of rHuEPO on perioperative erythropoiesis: Perioperative Hemoglobin, Hematocrit, serum EPO level', 'timeFrame': 'within the 1st postoperative hospital stay, up to 1 year', 'description': 'Perioperative Hemoglobin, Hematocrit, serum EPO level'}, {'measure': 'Effect of rHuEPO on perioperative erythropoiesis: GFR, BUN, Creatinine', 'timeFrame': 'within the 1st postoperative hospital stay, up to 1 year', 'description': 'GFR, BUN, Creatinine level'}, {'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', 'description': 'Clinical outcomes (4 grade): Excellent, Good, Fair, Poor'}, {'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', 'description': 'Brain Perfusion MRI (2 grade): Favorable, Unfavorable'}, {'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', 'description': 'Clinical outcomes (4 grade): Excellent, Good, Fair, Poor'}, {'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', 'description': 'Brain MRI/A or Brain perfusion MRI (2 grade): Favorable, Unfavorable'}, {'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', '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)'}, {'measure': 'Preoperative Cerebral angiography: Suzuki grade, Bilateral involvement', 'timeFrame': 'Before up to 1 year', 'description': 'Cerebral angiography: Suzuki grade(1-6), Bilateral involvement (yes/no)'}, {'measure': 'Preoperative Brain MRI/A or Brain Perfusion MRI', 'timeFrame': 'If the preoperative w/u is not completed before recruitment, up to 1 week', 'description': 'Brain MRI/A or Brain Perfusion MRI (2 grade): Favorable, Unfavorable'}, {'measure': 'Preoperative Hemoglobin, Hematocrit, serum EPO level', 'timeFrame': 'If the preoperative w/u is not completed before recruitment, up to 1 week', 'description': 'Preoperative Hemoglobin, Hematocrit, serum EPO level'}, {'measure': 'Preoperative information: Homozygous RNF213', 'timeFrame': 'If the preoperative w/u is not completed before recruitment, up to 1 week', 'description': 'Homozygous RNF213'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Moyamoya Disease', 'Pediatrics', 'Cerebrovascular Disorders']}, 'referencesModule': {'references': [{'pmid': '29626135', 'type': 'BACKGROUND', 'citation': 'Hong JM, Lee SJ, Lee JS, Choi MH, Lee SE, Choi JW, Lim YC. Feasibility of Multiple Burr Hole With Erythropoietin in Acute Moyamoya Patients. Stroke. 2018 May;49(5):1290-1295. doi: 10.1161/STROKEAHA.117.020566. Epub 2018 Apr 6.'}, {'pmid': '28277490', 'type': 'BACKGROUND', 'citation': 'Malla RR, Asimi R, Teli MA, Shaheen F, Bhat MA. Erythropoietin monotherapy in perinatal asphyxia with moderate to severe encephalopathy: a randomized placebo-controlled trial. J Perinatol. 2017 May;37(5):596-601. doi: 10.1038/jp.2017.17. Epub 2017 Mar 9.'}, {'pmid': '28703764', 'type': 'BACKGROUND', 'citation': 'Kimakova P, Solar P, Solarova Z, Komel R, Debeljak N. Erythropoietin and Its Angiogenic Activity. Int J Mol Sci. 2017 Jul 13;18(7):1519. doi: 10.3390/ijms18071519.'}, {'pmid': '28582302', 'type': 'BACKGROUND', 'citation': 'Aljaaly HA, Aldekhayel SA, Diaz-Abele J, Karunanayka M, Gilardino MS. Effect of Erythropoietin on Transfusion Requirements for Craniosynostosis Surgery in Children. J Craniofac Surg. 2017 Jul;28(5):1315-1319. doi: 10.1097/SCS.0000000000003717.'}, {'pmid': '27244862', 'type': 'BACKGROUND', 'citation': 'Wu YW, Mathur AM, Chang T, McKinstry RC, Mulkey SB, Mayock DE, Van Meurs KP, Rogers EE, Gonzalez FF, Comstock BA, Juul SE, Msall ME, Bonifacio SL, Glass HC, Massaro AN, Dong L, Tan KW, Heagerty PJ, Ballard RA. High-Dose Erythropoietin and Hypothermia for Hypoxic-Ischemic Encephalopathy: A Phase II Trial. Pediatrics. 2016 Jun;137(6):e20160191. doi: 10.1542/peds.2016-0191. Epub 2016 May 2.'}, {'pmid': '26846756', 'type': 'BACKGROUND', 'citation': 'Bang OY, Fujimura M, Kim SK. The Pathophysiology of Moyamoya Disease: An Update. J Stroke. 2016 Jan;18(1):12-20. doi: 10.5853/jos.2015.01760. Epub 2016 Jan 29.'}, {'pmid': '26846757', 'type': 'BACKGROUND', 'citation': 'Kim T, Oh CW, Bang JS, Kim JE, Cho WS. Moyamoya Disease: Treatment and Outcomes. J Stroke. 2016 Jan;18(1):21-30. doi: 10.5853/jos.2015.01739. Epub 2016 Jan 29.'}, {'pmid': '22027622', 'type': 'BACKGROUND', 'citation': 'Yoo YC, Shim JK, Kim JC, Jo YY, Lee JH, Kwak YL. Effect of single recombinant human erythropoietin injection on transfusion requirements in preoperatively anemic patients undergoing valvular heart surgery. Anesthesiology. 2011 Nov;115(5):929-37. doi: 10.1097/ALN.0b013e318232004b.'}, {'pmid': '20582955', 'type': 'BACKGROUND', 'citation': 'Kim SK, Cho BK, Phi JH, Lee JY, Chae JH, Kim KJ, Hwang YS, Kim IO, Lee DS, Lee J, Wang KC. Pediatric moyamoya disease: An analysis of 410 consecutive cases. Ann Neurol. 2010 Jul;68(1):92-101. doi: 10.1002/ana.21981.'}, {'pmid': '19774676', 'type': 'BACKGROUND', 'citation': 'Kim JH, Jung JH, Phi JH, Kang HS, Kim JE, Chae JH, Kim SJ, Kim YH, Kim YY, Cho BK, Wang KC, Kim SK. Decreased level and defective function of circulating endothelial progenitor cells in children with moyamoya disease. J Neurosci Res. 2010 Feb 15;88(3):510-8. doi: 10.1002/jnr.22228.'}, {'pmid': '12702503', 'type': 'BACKGROUND', 'citation': 'Heeschen C, Aicher A, Lehmann R, Fichtlscherer S, Vasa M, Urbich C, Mildner-Rihm C, Martin H, Zeiher AM, Dimmeler S. Erythropoietin is a potent physiologic stimulus for endothelial progenitor cell mobilization. Blood. 2003 Aug 15;102(4):1340-6. doi: 10.1182/blood-2003-01-0223. Epub 2003 Apr 17.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric Moyamoya patients scheduled for the first revascularization surgery\n\nExclusion Criteria:\n\n* Hypersensitivity or contraindication to rHuEPO\n* History of Unstable hypertension, Hypertensive encephalopathy, Thrombosis\n* Primary intracerebral hemorrhage (ICH), Subarachnoid hemorrhage (SAH), Arterio-venous malformation (AVM), Cerebral aneurysm, or cerebral neoplasm\n* History of seizure\n* Hemoglobin \\>16 mg/dl\n* Prolonged PT (PT \\> 15.5 seconds, PT INR \\> 1.2) or Prolonged aPTT (\\> 40 seconds)\n* Thrombocytopenia (platelet count \\< 100,000/microL), Thrombocytosis (platelet count \\> 400,000/microL), Neutropenia (absolute neutrophil count (ANC) \\< 1500/microL)\n* Abnormal kidney function (Creatinine\\> 2.0 mg/dl, History of dialysis)\n* Abnormal hepatic function (aspartate transaminase\\> 80 unit/L, alanine aminotransferase\\> 80 unit/L)'}, 'identificationModule': {'nctId': 'NCT03882060', 'briefTitle': 'Effect of Recombinant Human EPO on the Postoperative Neurologic Outcome in Pediatric Moyamoya Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effect of Recombinant Human Erythropoietin on the Postoperative Neurologic Outcome in Pediatric Moyamoya Disease Patients - A Double Blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'H-1812-165-999'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rHuEPO', '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)', 'interventionNames': ['Drug: erythropoietin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Normal saline 50mL x 3 times Preoperative day (12-24 hour before surgery) During surgery Postoperative day (12-24 hour after surgery)', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'erythropoietin', 'type': 'DRUG', 'otherNames': ['rHuEPO'], 'description': 'Recombinant human erythropoietin (500 U/kg IVS x 3 times) is administrated to increase the neovascularization after revascularization surgery.', 'armGroupLabels': ['rHuEPO']}, {'name': 'Normal saline', 'type': 'DRUG', 'otherNames': ['Control'], 'description': 'Control group, no intervention.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}