UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046369 |
|---|---|
| Receipt number | R000052912 |
| Scientific Title | Carboxyhemoglobin levels as a marker of hemolysis during extracorporeal membrane oxygenation |
| Date of disclosure of the study information | 2021/12/15 |
| Last modified on | 2024/12/16 10:01:27 |
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Basic information
Public title
Carboxyhemoglobin levels as a marker of hemolysis during extracorporeal membrane oxygenation
Acronym
Carboxyhemoglobin levels as a marker of hemolysis during extracorporeal membrane oxygenation
Scientific Title
Carboxyhemoglobin levels as a marker of hemolysis during extracorporeal membrane oxygenation
Scientific Title:Acronym
Carboxyhemoglobin levels as a marker of hemolysis during extracorporeal membrane oxygenation
Region
| Japan |
Condition
Condition
Patients admitted to the ICU
Classification by specialty
| Cardiology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessing to the efficacy of carboxyhemoglobin levels as a marker of hemolysis during extracorporeal membrane oxygenation
Basic objectives2
Others
Basic objectives -Others
Investigating the trend of carboxyhemoglobin levels during extracorporeal membrane oxygenation
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Carboxyhemoglogin levels among patients with hemolysis and patients without hemolysis
Key secondary 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
ICU patients
Requires ECMO
Key exclusion criteria
Multiple ECMO run(s) during the study period
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kimura |
Organization
Okayama University Hospital
Division name
Department of Anesthesiology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-shi
TEL
0862357778
kimsato1034@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kimura |
Organization
Okayama University Hospital
Division name
Department of Anesthesiology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-shi
TEL
0862357778
Homepage URL
kimsato1034@hotmail.co.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Okayama University
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-shi
Tel
0862356938
mae6605@adm.okayama-u.ac.jp
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
| 2021 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
34
Results
PFH, COHb, and MetHb levels during ECMO did not show major changes in all patients. In the hemolysis group, COHb levels showed an upward trend, as did PFH, while MetHb increased immediately after the initiation of ECMO. The maximum MetHb levels during ECMO were significantly higher in the hemolysis group and had a slightly better predictive ability for hemolysis
Results date posted
| 2024 | Year | 12 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who required ECMO management due to circulatory or respiratory failure
Participant flow
The informed written consent of each patient or their legal representative was obtained during the ECMO requirement.
Adverse events
None
Outcome measures
The primary aim was to investigate whether in COHb and MetHb levels, as well as PFH, increased during ECMO and compare PFH, COHb and MetHb levels between patients with and without hemolysis during ECMO
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2021 | Year | 12 | Month | 14 | Day |
Last modified on
| 2024 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052912
