UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045790 |
|---|---|
| Receipt number | R000052276 |
| Scientific Title | A prospective study of the effect of PFH (plasma free hemoglobin) on outcomes in ECMO patients |
| Date of disclosure of the study information | 2021/10/20 |
| Last modified on | 2021/10/19 00:29:06 |
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Basic information
Public title
A prospective study of the effect of PFH (plasma free hemoglobin) on outcomes in ECMO patients
Acronym
Effect of PFH on outcome in ECMO patients
Scientific Title
A prospective study of the effect of PFH (plasma free hemoglobin) on outcomes in ECMO patients
Scientific Title:Acronym
Effect of PFH on outcome in ECMO patients
Region
| Japan |
Condition
Condition
Severe respiratory failure, Severe heart failure, Cardiac arrest
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the correlation between changes in PFH levels in ECMO patients and ECMO equipment troubles and complications such as hemolysis and thrombosis
Basic objectives2
Others
Basic objectives -Others
Improve outcomes in ECMO patients
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
90-day mortality rate
Key secondary outcomes
ECMO equipment troubles, hemolysis and thrombosis
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ECMO patients in ICU
Key exclusion criteria
Chronic dialysis patients, Patients with hematological disease
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Ryuzo |
| Middle name | |
| Last name | Abe |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Emergency and Critical Care Medicine
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba city
TEL
043-226-2341
chibadaieccm-office@umin.ac.jp
Public contact
Name of contact person
| 1st name | Natsumi |
| Middle name | |
| Last name | Suga |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Emergency and Critical Care Medicine
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba city
TEL
043-226-2341
Homepage URL
natsumi_u_0809@yahoo.co.jp
Sponsor or person
Institute
Graduate School of Medicine, Chiba University
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
Chiba University Hospital Clinical Research Center
Address
1-8-1 Inohana Chuo-ku Chiba 260-8677, JAPAN
Tel
0432227171
chibadaieccm-office@umin.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 | 10 | Month | 20 | 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
| 2021 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Baseline characteristics
APACHE score, SOFA score
ECMO implementation method, ECMO days
needs Extracorporeal circulatory system except ECMO or not
Blood test findings(Hb, BNP, Cre, IL-6, CRP)
Water balance
Ventilator free days
ICU length of stay
90-day mortality
Management information
Registered date
| 2021 | Year | 10 | Month | 19 | Day |
Last modified on
| 2021 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052276
