UMIN-CTR Clinical Trial

Basic information
Public title	Time-dependent coagulation changes in acute normovolemic hemodilutional blood
Acronym	Coagulation status of acute normovolemic hemodilutional blood
Scientific Title	Time-dependent coagulation changes in acute normovolemic hemodilutional blood
Scientific Title:Acronym	Coagulation status of acute normovolemic hemodilutional blood
Region	Japan

Condition
Condition	Malignancy
Classification by specialty	Hepato-biliary-pancreatic medicine Surgery in general Obsterics and gynecology Oto-rhino-laryngology Orthopedics Cardiovascular surgery Blood transfusion
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine how long the acute normovolemic hemodilutional blood maintains the coagulation status.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A10 and maximum clot firmness (MCF) of INTEM, EXTEM and FIBTEM (ROTEM deltaTM) of autologous 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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who receive acute normovolemic hemodilution under general anesthesia
Key exclusion criteria	Patients who refuse to join the study
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Junichi Middle name Last name Saito
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Anesthesiology
Zip code	0358563
Address	zaifu-cho 5, Hirosaki, Aomori, Japan
TEL	0172-39-5113
Email	saitoj@hirosaki-u.ac.jp

Public contact
Name of contact person	1st name Junichi Middle name Last name Saito
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Anesthesiology
Zip code	0368563
Address	zaifu-cho 5, Hirosaki, Aomori, Japan
TEL	0172-39-5113
Homepage URL
Email	saitoj@hirosaki-u.ac.jp

Sponsor
Institute	Hirosaki University Graduate School of Medicine, department of Anesthesiology
Institute
Department

Funding Source
Organization	Hirosaki University Graduate School of Medicine, department of Anesthesiology
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	institutional review board, Hirosaki University Graduate School of Medicine
Address	zaifu-cho5, Hirosaki
Tel	0172335113
Email	saitoj@hirosaki-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	2018 Year 07 Month 01 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	Main results already published
Date of protocol fixation	2018 Year 06 Month 10 Day
Date of IRB	2018 Year 06 Month 11 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date	2020 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	we evaluate the coagulation status of the autologous blood. we measure twice using with ROTEM deltaTM just after withdrawing the blood and just before retransfusion to the patients.

Management information
Registered date	2018 Year 06 Month 15 Day
Last modified on	2021 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037638