UMIN-CTR Clinical Trial

Basic information
Public title	Observational study of heparin/protamine effects during extracorporeal circulation
Acronym	Heparin/protamine effects on cardiac function
Scientific Title	Observational study of heparin/protamine effects during extracorporeal circulation
Scientific Title:Acronym	Heparin/protamine effects on cardiac function
Region	Japan

Condition
Condition	cardiovascular surgery patients receiving extracorporeal circulation
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	evaluation of drug effects on post-operative arrythmias during extracorporeal circulation
Basic objectives2	Others
Basic objectives -Others	mechanism of heparin-protamine side effects
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Optimal dosis of Heparin-protamine during extracorporeal circulation
Key secondary outcomes	Factors affecting post-operative atrial fibrillation and other arrythmias

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Provide signed, written informed consent. 2.Patient to perform an operation using heparin/protamine
Key exclusion criteria	cardiovascular surgery patients without extracorporeal circulation
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yasuharu Middle name Last name Yamada
Organization	Suzuka University of Medical Science
Division name	Department of Clinical Engineering, Faculty of Medical Engineering
Zip code	5100293
Address	1001-1 Kishioka, Suzuka, Mie510-0293, Japan
TEL	059-383-8991
Email	yamada@suzuka-u.ac.jp

Public contact
Name of contact person	1st name Yasuharu Middle name Last name Yamada
Organization	Suzuka University of Medical Science
Division name	Department of Clinical Engineering, Faculty of Medical Engineering
Zip code	5100293
Address	1001-1 Kishioka, Suzuka, Mie510-0293, Japan
TEL	059-383-8991
Homepage URL
Email	yamada@suzuka-u.ac.jp

Sponsor
Institute	Department of Clinical Engineering, Faculty of Medical Engineering, Suzuka University of Medical Science
Institute
Department

Funding Source
Organization	Department of Clinical Engineering, Faculty of Medical Engineering, Suzuka University of Medical Science
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	Okanami General Hospital
Address	1734 Ueno-Kuwamachi, Iga, Mie
Tel	0595-21-3135
Email	info@okanami.com

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	鈴鹿医療科学大学（三重県）

Other administrative information
Date of disclosure of the study information	2021 Year 07 Month 21 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	2019 Year 12 Month 05 Day
Date of IRB	2020 Year 02 Month 10 Day
Anticipated trial start date	2020 Year 02 Month 10 Day
Last follow-up date	2030 Year 02 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study of heparin-protamine effects on arrythmias during extracorporeal circulation

Management information
Registered date	2021 Year 07 Month 21 Day
Last modified on	2021 Year 07 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051148