UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The evaluation of coagulation ability at leaving crdio-pulmonary bypass in cardiovascular surgery
Title of the study (Brief title)	The evaluation of coagulation ability at leaving crdio-pulmonary bypass in cardiovascular surgery
Region	Japan

Condition
Condition	Acute aortic disection Thoracic aortic aneurysm re-cardio-vascular surgery
Classification by specialty	Anesthesiology Cardiovascular surgery Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The evaluation of coagulation ability at leaving cardio-pulmonary bypass
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	result of thromboelastography after leaving cardio pulmonary bypass and administrating protamine
Key secondary outcomes	relationship with other blood examination total of bleeding amount of postoperative transfusion

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	befor leaving cardio-pulmonary bypass, FFP4Unit is administrated. after leaving cardio-pulmonary bypass, FFP4Unit is administrated.
Interventions/Control_2	befor leaving cardio-pulmonary bypass, FFP isn't administrated. after leaving cardio-pulmonary bypass, FFP8Unit is administrated.
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	Cardiovascular surgery cases with using FFP and/or PC : Acute aortic disection, Thorasic aortic aneurysm, Re-cardiovascular surgery
Key exclusion criteria	incompatibility using FFP, PC, heaprin, protamine When FFP and PC deviate from the prescribed time. The patient is judged that joining to this study is inappropriate
Target sample size	30

Research contact person
Name of lead principal investigator	Takahiro Tamura
Organization	Japanease red cross nagoya daiichi hospital
Division name	Anesthesiology
Address	35, Michisita-cho 3, Nakamura-ku, Nagoya city, Aichi, Japan
TEL	0524815111
Email	takahiro@nagoya-1st.jrc.or.jp

Public contact
Name of contact person	Takahiro Tamura
Organization	Japanease red cross nagoya daiichi hospital
Division name	Anesthesiology
Address	35, Michisita-cho 3, Nakamura-ku, Nagoya city, Aichi, Japan
TEL	0524815111
Homepage URL
Email	takahiro@nagoya-1st.jrc.or.jp

Sponsor
Institute	Nagoya university graduste school of medicine
Institute
Department

Funding Source
Organization	Japanease red cross nagoya daiichi hospital
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	2016 Year 04 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 25 Day
Anticipated trial start date	2016 Year 04 Month 25 Day
Last follow-up date	2017 Year 02 Month 13 Day
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

Management information
Registered date	2016 Year 03 Month 30 Day
Last modified on	2017 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025007