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Effect of Recombinant Human EPO on the Postoperative Neurologic Outcome in Pediatric Moyamoya Patients

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ClinicalTrials.gov Identifier: NCT03882060
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Moyamoya Disease Pediatrics Cerebrovascular Disorders Drug: erythropoietin Drug: Normal saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Recombinant Human Erythropoietin on the Postoperative Neurologic Outcome in Pediatric Moyamoya Disease Patients - A Double Blind Randomized Controlled Trial
Actual Study Start Date : April 8, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: rHuEPO
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)
Drug: erythropoietin
Recombinant human erythropoietin (500 U/kg IVS x 3 times) is administrated to increase the neovascularization after revascularization surgery.
Other Name: rHuEPO

Placebo Comparator: Control
Normal saline 50mL x 3 times Preoperative day (12-24 hour before surgery) During surgery Postoperative day (12-24 hour after surgery)
Drug: Normal saline
Control group, no intervention.
Other Name: Control




Primary Outcome Measures :
  1. postoperative 3~6 month Angiogenesis [ Time Frame: 3~6 month after revascularization operation ]
    Incidence of Good postoperative MCA territory revascularization by cerebral angiography (3 grade: good, fair, poor)


Secondary Outcome Measures :
  1. Short-term postoperative outcome: Incidence and number of the postoperative transient ischemic attack (TIA) within 1 week [ Time Frame: up to 1 week ]
    Incidence and number of the postoperative transient ischemic attack (TIA) within 1 week (yes or no)

  2. Short-term postoperative outcome: Adverse neurologic event [ Time Frame: within the 1st postoperative hospital stay, up to 1 year ]
    seizure, increased intracranial pressure, cerebral infarct, hematoma, reoperation (yes or no)

  3. Short-term postoperative outcome: Other postoperative complications [ Time Frame: within the 1st postoperative hospital stay, up to 1 year ]
    e.g. Circulatory failure/arrest, Respiratory failure/arrest, Infection (yes or no)

  4. Short-term postoperative outcome: ICU stay (days) [ Time Frame: within the 1st postoperative hospital stay, up to 1 year ]
    ICU stay (discharge criteria: Stable V/S + Consciousness)

  5. Short-term postoperative outcome: Total hospital stay (days) [ Time Frame: within the 1st postoperative hospital stay, up to 1 year ]
    Total hospital stay (discharge criteria: Stable V/S + no progressive Sx)

  6. 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 ]
    Total intraoperative and perioperative transfusion requirements (mL/kg)

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

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

  9. Postoperative 3~6 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 ]
    Clinical outcomes (4 grade): Excellent, Good, Fair, Poor

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

  11. 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 ]
    Clinical outcomes (4 grade): Excellent, Good, Fair, Poor

  12. 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 ]
    Brain MRI/A or Brain perfusion MRI (2 grade): Favorable, Unfavorable

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

  14. Preoperative Cerebral angiography: Suzuki grade, Bilateral involvement [ Time Frame: Before up to 1 year ]
    Cerebral angiography: Suzuki grade(1-6), Bilateral involvement (yes/no)

  15. Preoperative Brain MRI/A or Brain Perfusion MRI [ Time Frame: If the preoperative w/u is not completed before recruitment, up to 1 week ]
    Brain MRI/A or Brain Perfusion MRI (2 grade): Favorable, Unfavorable

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

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



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03882060


Contacts
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Contact: Jin-Tae e Kim, MD, PhD 82-2-2072-3664 jintae73@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Jin-Tae Kim, MD. PhD.    82-2-2072-3664    kimjintae73@dreamwiz.com   
Sponsors and Collaborators
Seoul National University Hospital

Publications:

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Responsible Party: Jin-Tae Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03882060     History of Changes
Other Study ID Numbers: H-1812-165-999
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cerebrovascular Disorders
Moyamoya Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Epoetin Alfa
Hematinics