UMIN-CTR Clinical Trial

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
Email	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
Email	natsumi_u_0809@yahoo.co.jp

Sponsor
Institute	Graduate School of Medicine, Chiba University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052276