UMIN-CTR Clinical Trial

Basic information
Public title	Effect of rotational thromboelastometry on mortality and bleeding outcome in cardiovascular surgery: A cohort Study
Acronym	Thromboelastometry and clinical outcomes
Scientific Title	Effect of rotational thromboelastometry on mortality and bleeding outcome in cardiovascular surgery: A cohort Study
Scientific Title:Acronym	Thromboelastometry and clinical outcomes
Region	Japan

Condition
Condition	The study was completed
Classification by specialty	Chest surgery Anesthesiology Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The clinical importance of hemostatic assessment with a viscoelastic device in cardiovascular surgery remains unclear. This study aimed to determine whether a blood transfusion protocol with rotational thromboelastometry could reduce mortality, bleeding complication, and blood transfusion rates in cardiac surgery or thoracic aortic surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	All-cause mortality, re-exploration for bleeding, major bleeding
Key secondary outcomes	Blood transfusion rate

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	A cohort of consecutive cardiovascular surgery patients with Cardiopulmonary bypass.
Key exclusion criteria	No exclusion criteria were used in this study.
Target sample size	370

Research contact person
Name of lead principal investigator	1st name Mutsuhito Middle name Last name Kikura
Organization	Hamamatsu Rosai Hospital, Japan Organization of Occupational Health and Safety
Division name	Department of Anesthesiology
Zip code	430-8525
Address	25 Shogen-cho, Higashi-ku, Hamamatsu 430-8525, Japan
TEL	++81-53-462-1211
Email	mkikura@hotmail.com

Public contact
Name of contact person	1st name Mutsuhito Middle name Last name Kikura
Organization	Hamamatsu Rosai Hospital, Japan Organization of Occupational Health and Safety
Division name	Department of Anesthesiology
Zip code	430-8525
Address	25 Shogen-cho, Higashi-ku, Hamamatsu 430-8525, Japan
TEL	++81-53-462-1211
Homepage URL
Email	mkikura@hotmail.com

Sponsor
Institute	Hamamatsu Rosai Hospital, Japan Organization of Occupational Health and Safety
Institute
Department

Funding Source
Organization	Hamamatsu Rosai Hospital, Japan Organization of Occupational Health and Safety
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Hamamatsu Rosai Hospital, Japan Organization of Occupational Health and Safety
Address	25 Shogen-cho, Higashi-ku, Hamamatsu 430-8525, Japan
Tel	++81-53-462-1211
Email	soumuka@hamamatsuh.johas.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	2020 Year 01 Month 31 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	370
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	2010 Year 01 Month 01 Day
Date of IRB	2018 Year 03 Month 09 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

We retrospectively studied a cohort of 376 consecutive patients who underwent cardiopulmonary bypass before (control group: 150 cardiac and 35 thoracic aortic surgeries) and after (assessment group: 154 cardiac and 37 thoracic aortic surgeries) introducing the point-of-care assessment with thromboelastometry in the blood transfusion protocol. We compared the difference in all-cause mortality, re-exploration for bleeding, major bleeding, and blood transfusion rate between the control and assessment groups.

Management information
Registered date	2020 Year 01 Month 31 Day
Last modified on	2020 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044864