UMIN-CTR Clinical Trial

Basic information
Public title	Rocuronium concentration of cell saver blood following cardiac surgery
Acronym	Rocuronium concentration of cell saver blood following cardiac surgery
Scientific Title	Rocuronium concentration of cell saver blood following cardiac surgery
Scientific Title:Acronym	Rocuronium concentration of cell saver blood following cardiac surgery
Region	Japan

Condition
Condition	single heart valve repair or replacement or similar non-invasive cardiac surgery
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To measure rocuronium concentration of cell saver blood
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rocuronium concentration of cell saver blood
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patient who is receiving single heart valve repair or replacement or similar relatively low invasive cardiac surgery use of cell saver during cardiac surgery
Key exclusion criteria	patient who is allergic to muscle relaxants
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Hajime Middle name Last name Iwasaki
Organization	Nihon University School of Medicine
Division name	Department of Anesthesiology
Zip code	1738610
Address	30-1, Oyaguchi Kamicho, Itabashi-Ku, Tokyo, Japan
TEL	+81-3-3972-8111
Email	iwasaki.hajime@nihon-u.ac.jp

Public contact
Name of contact person	1st name Hajime Middle name Last name Iwasaki
Organization	Nihon University School of Medicine
Division name	Department of Anesthesiology
Zip code	1738610
Address	+81-3-3972-8111
TEL	+81-3-3972-8111
Homepage URL
Email	iwasaki.hajime@nihon-u.ac.jp

Sponsor
Institute	Nihon University School of Medicine
Institute
Department

Funding Source
Organization	Nihon University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address	30-1, Oyaguchi Kamicho, Itabashi-Ku, Tokyo, Japan
Tel	+81-3-3972-8111
Email	komoda.nozomi@nihon-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	2020 Year 06 Month 24 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	10
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	Completed
Date of protocol fixation	2020 Year 05 Month 01 Day
Date of IRB	2020 Year 06 Month 19 Day
Anticipated trial start date	2020 Year 06 Month 25 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	not applicable

Management information
Registered date	2020 Year 06 Month 24 Day
Last modified on	2021 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046676