UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical evaluation on activation of coagulation and fibrinolytic system during major cardiovascular surgery
Title of the study (Brief title)	Clinical evaluation on activation of coagulation and fibrinolytic system during major cardiovascular surgery
Region	Japan

Condition
Condition	major cardiovascular surgery with use of cardiopulmonary bypass
Classification by specialty	Anesthesiology Cardiovascular surgery Blood transfusion
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to evaluate the activation of coagulation and fibrinolytic pathway during cardiopulmonary bypass in aortic replacement surgery in comparison with other cardiopulmonary surgery
Basic objectives2	Others
Basic objectives -Others	observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	activated factor VII, thrombin-antithrombin complex (TAT), fibrin monomer, fibrin degradation product (FDP), D-dimer, plasmin-plasmin inhibitor complex (PIC), fibrinogen, PT, APTT, platelet count, hemoglobin, from just before the start of cardiopulmonary bypass until entrance into the intensive care unit
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	aortic replacement surgery,other cardiovascular surgery,re-surgery for cardiovascular replacement
Key exclusion criteria	patients with congenital bleeding diathesis, patients with thrombocytopenia less than 100,000/uL continuing more than one month, patients with taking oral anticoagulant/antiplatelet agents
Target sample size	60

Research contact person
Name of lead principal investigator	SATO HIDEO
Organization	Teikyo University Hospital
Division name	anesthesiology
Address	2-11-1 Kaga,Itabashi-ku,Tokyo 173-8605 JAPAN
TEL	03-3964-1211
Email	hideos3150@yahoo.co.jp

Public contact
Name of contact person	SATO HIDEO
Organization	Teikyo University Hospital
Division name	anesthesiology
Address	2-11-1 Kaga,Itabashi-ku,Tokyo 173-8605 JAPAN
TEL	03-3964-1211
Homepage URL
Email	hideos3150@yahoo.co.jp

Sponsor
Institute	Teikyo University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Teikyo University Hospital department of anesthesiology
Organization
Division
Category of Funding Organization	Other
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	2013 Year 06 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 13 Day
Anticipated trial start date	2013 Year 04 Month 14 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	Published
URL releasing results
Results
Other related information	To evaluate the activation of coagulation and fibrinolytic pathway during cardiopulmonary bypass in aortic replacement surgery in comparison with other cardiovascular surgery prospective study

Management information
Registered date	2013 Year 06 Month 04 Day
Last modified on	2016 Year 07 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012663