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

November 21, 2023 updated by: Jin-Tae Kim, Seoul National University Hospital

The Effect of Recombinant Human Erythropoietin on the Postoperative Neurologic Outcome in Pediatric Moyamoya Disease Patients - A Double Blind Randomized Controlled Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative <12 month Angiogenesis
Time Frame: <12 month after revascularization operation
Incidence of Good postoperative MCA territory revascularization by cerebral angiography or MRI (3 grade: good, fair, poor)
<12 month after revascularization operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 1 week
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)
within the 1st postoperative hospital stay, up to 1 year
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)
within the 1st postoperative hospital stay, up to 1 year
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)
within the 1st postoperative hospital stay, up to 1 year
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)
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
Total intraoperative and perioperative transfusion requirements (mL/kg)
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
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
Time Frame: within the 1st postoperative hospital stay, up to 1 year
GFR, BUN, Creatinine level
within the 1st postoperative hospital stay, up to 1 year
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
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
Time Frame: Outpatient clinical visit, Usually Postoperative 3~6 month, up to 1 year
Brain Perfusion MRI (2 grade): Favorable, Unfavorable
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
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
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
Outpatient clinical visit, Usually Postoperative 12~18 month, up to 2 years
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)
Outpatient clinical visit, Usually Postoperative 12~18 month, up to 2 years
Preoperative Cerebral angiography: Suzuki grade, Bilateral involvement
Time Frame: Before up to 1 year
Cerebral angiography: Suzuki grade(1-6), Bilateral involvement (yes/no)
Before 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
Brain MRI/A or Brain Perfusion MRI (2 grade): Favorable, Unfavorable
If the preoperative w/u is not completed before recruitment, up to 1 week
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
If the preoperative w/u is not completed before recruitment, up to 1 week
Preoperative information: Homozygous RNF213
Time Frame: If the preoperative w/u is not completed before recruitment, up to 1 week
Homozygous RNF213
If the preoperative w/u is not completed before recruitment, up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2019

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

March 12, 2019

First Submitted That Met QC Criteria

March 16, 2019

First Posted (Actual)

March 20, 2019

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1812-165-999

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebrovascular Disorders

Clinical Trials on erythropoietin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe