UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030967 |
|---|---|
| Receipt number | R000034927 |
| Scientific Title | The National Hospital Organization study for creating the daily-predicting score for successful weaning from percutaneous cardio-pulmonary support |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2021/06/08 15:43:55 |
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Basic information
Public title
The National Hospital Organization study for creating the daily-predicting score for successful weaning from percutaneous cardio-pulmonary support
Acronym
NHOC-PCPS
Scientific Title
The National Hospital Organization study for creating the daily-predicting score for successful weaning from percutaneous cardio-pulmonary support
Scientific Title:Acronym
NHOC-PCPS
Region
| Japan |
Condition
Condition
Cardiovascular diseases
Classification by specialty
| Cardiology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To create the predicting score using background and daily-fluctuatin factors for successful weaning from PCPS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Factors affecting successful weaning from PCPS:
Background factors; 1) age, 2) time to induction (within 30 minutes), 3) underlying heart diseases (ischemic heart disease with successful revascularization, acute myocarditis, pulmonary embolism), 4) creatinine value at PCPS induction,
Daily factors; 5) PCPS flow rate/rotation speed, 6) use of IABP, 7) use of hemodialysis, 8) blood pressure, 9) lactate level, 10) total bilirubin value,11) hemorrhagic complications.
Regression coefficient in the prediction model for PCPS discontinuation.
Key secondary outcomes
Predicted value and measured value by the prediction model for PCPS successful weaning.
Proportion of in-hospital death and survival discharge after PCPS successful weaning.
Neurological prognosis.
Number of days before PCPS discontinuation, survival discharge, and in-hospital death.
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
| 2 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who have been treated with PCPS during the period from April 1, 2012 to March 31, 2020
Key exclusion criteria
(1) Patients who have difficulties to discontinue PCPS after on-pompcardiovascular surgery
(2) In a case when the patients or patients' guardian (parental authority) provid disagreement for participating this study
(3) Patients whose principal investigators or sub-investigators consider unsuitable to participate in this study
(4) Patients under 2-year-old at the time of PCPS induction
(5) Patient using VV-ECMO
(6) The patient who was scheduled PCPS for coronary intervention or catheter ablation
Target sample size
410
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Watanabe |
Organization
National Hospital Organization Yokohama Medical Center
Division name
Cardiology
Zip code
245-8575
Address
3-60-2, Harajyuku, Totsuka-ku, Yokohama-shi, Kanagawa
TEL
045-851-2621
mshrwtnb21@hotmail.com
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Ajiro |
Organization
National Hospital Organization Yokohama Medical Center
Division name
Cardiology
Zip code
245-8575
Address
3-60-2, Harajyuku, Totsuka-ku, Yokohama-shi, Kanagawa
TEL
045-851-2621
Homepage URL
you617bacchus@gmail.com
Sponsor or person
Institute
National Hospital Organization Yokohama Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization
Address
2-5-21, Higashigaoka, Meguro-ku, Tokyo
Tel
03-5712-5050
kenkyu2004@hosp.go.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
| 2018 | Year | 02 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient who have been treated with PCPS during the period from April 1, 2012 to March 31, 2020 at the participation plans facility .
Retrospective observational study
Management information
Registered date
| 2018 | Year | 01 | Month | 24 | Day |
Last modified on
| 2021 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034927
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
