UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Coaglation and fibrinolytic function in use of intraoperative blood salvage for cardiovasucular surgery
Title of the study (Brief title)	Blood salvage and coagulation function
Region	Japan

Condition
Condition	patients undergoing cardiovascular surgeries
Classification by specialty	Anesthesiology Cardiovascular surgery Blood transfusion
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore mechanisms of coagulation dysfunction in blood salvage in vitro preparation
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fibtem MCF (maximum Clot Firmness) obtained from thoromboelastometry
Key secondary outcomes	Extem MCF and CT obtained form thoronboelastometry

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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients undergoing scheduled cardiovascular surgeries 2. Patients prepared for use of blood slvage
Key exclusion criteria	1. Patients undergoing emergency surgeries 2. Patients with hematologic diseases 3. Patients with contraindication for use of heparin
Target sample size	55

Research contact person
Name of lead principal investigator	Son Kyongsuk
Organization	Chiba University Hospital
Division name	Department of Anesthesiology
Address	1-8-1 Inohana-cho, Chuo-ku, Chiba
TEL	043-222-7171
Email	kyong0203suk@yahoo.co.jp

Public contact
Name of contact person	Son Kyongsuk
Organization	Chiba University Hospital
Division name	Department of Anesthesiology
Address	1-8-1 Inohana-cho, Chuo-ku, Chiba
TEL	043-222-7171
Homepage URL
Email	kyong0203suk@yahoo.co.jp

Sponsor
Institute	Department of Anesthesiology, Chiba University Hosppital
Institute
Department

Funding Source
Organization	Institutional
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2015 Year 11 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 09 Day
Anticipated trial start date	2015 Year 11 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	By using thoromboelastometry, we plan to exlore presence of does dependence of coagulation dysfunction and determine independent factors for the coagulation dysfunction. When the investigators work in the operating room, the first 65 patients fulfilling the inclusion criteria will be studied during the study period.

Management information
Registered date	2015 Year 11 Month 10 Day
Last modified on	2018 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022782