UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062954 |
|---|---|
| Receipt number | R000072075 |
| Scientific Title | A Multicenter Retrospective Registry Study of Survival and Complications in Pediatric ECMO |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/16 19:42:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Request for Cooperation in a Retrospective Registry (Clinical Database) Study of Pediatric ECMO Cases in Japan
Acronym
Japan Pediatric ECMO Registry
Scientific Title
A Multicenter Retrospective Registry Study of Survival and Complications in Pediatric ECMO
Scientific Title:Acronym
Japan Pediatric ECMO Registry
Region
| Japan |
Condition
Condition
Critically ill pediatric patients requiring extracorporeal membrane oxygenation (ECMO)
Classification by specialty
| Pediatrics | Cardiovascular surgery | Emergency medicine |
| Intensive care medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to characterize clinical outcomes, complications, and indications for ECMO in pediatric patients in Japan using multicenter data, and to evaluate the associations of patient characteristics and treatment-related factors with outcomes.
Basic objectives2
Others
Basic objectives -Others
Epidemiological study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival to hospital discharge
Key secondary outcomes
Incidence of ECMO-related complications; clinical outcomes according to ECMO modality (VA, VV, and ECPR); associations between devices used (pump and oxygenator) and outcomes; associations between indications for ECMO (e.g., cardiac failure and respiratory failure) and outcomes; and associations of ECPR and CPR duration with outcomes.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | days-old | <= |
Age-upper limit
| 17 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who received ECMO between January 1, 2019 and December 31, 2023.
Patients for whom the required clinical information is available from medical records.
Patients younger than 18 years of age at the initiation of ECMO.
Key exclusion criteria
Patients who opted out of participation in the study.
Patients with missing data on the primary outcome.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Wataru |
| Middle name | |
| Last name | Sakai |
Organization
Sapporo Medical University of Medicine
Division name
Department of Anesthesiology
Zip code
006-0041
Address
West 16, South 1, Chuo-ku, Sapporo, Hokkaido
TEL
0116915696
sakaiwataru1128@gmail.com
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Sakai |
Organization
Sapporo Medical University of Medicine
Division name
Department of Anesthesiology
Zip code
006-0041
Address
West 16, South 1, Chuo-ku, Sapporo, Hokkaido
TEL
0116915696
Homepage URL
sakaiwataru1128@gmail.com
Sponsor or person
Institute
Sapporo Medical University of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University of Medicine
Address
West 16, South 1, Chuo-ku, Sapporo, Hokkaido
Tel
0116889663
sakaiwataru1128@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter retrospective observational study. Pediatric patients younger than 18 years of age who received ECMO between January 1, 2019 and December 31, 2023 will be included. Existing clinical data will be retrospectively collected from medical records at participating institutions. No additional intervention or examination will be performed for study participants. Clinical outcomes, ECMO-related complications, and clinical factors associated with outcomes will be analyzed.
Management information
Registered date
| 2026 | Year | 09 | Month | 16 | Day |
Last modified on
| 2026 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072075
