UMIN-CTR Clinical Trial

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
Email	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
Email	you617bacchus@gmail.com

Sponsor
Institute	National Hospital Organization Yokohama Medical Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034927