UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044929
Receipt number R000051148
Scientific Title Observational study of heparin/protamine effects during extracorporeal circulation
Date of disclosure of the study information 2021/07/21
Last modified on 2021/07/21 11:01:06

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051148


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name