UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of a fresh frozen plasma dosage and administration timing, and the protamine dose before and after cardio-pulmonary bypass.
Title of the study (Brief title)	Change of the blood coagulation system before and after cardio-pulmonary bypass.
Region	Japan

Condition
Condition	the case of cardiovascular surgery
Classification by specialty	Anesthesiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to detect degree of the coagulation and fibrinolysis change before and after cardio-pulmonary bypass using by ROTEM, and to clarify index of the optimal protamine dosage aims at the establishment of an appropriate blood transfusion therapy by this monitoring in the future.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Examination of protamine initial dosage at the time of the cardio-pulmonary bypass and the additional dose
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients performed cardio-vascular surgery
Key exclusion criteria	The person who do not hop to be a target person. Person having blood disorder. The person whose a record is insufficient.
Target sample size	40

Research contact person
Name of lead principal investigator	Kazuhiro Shirozu
Organization	Kyushu university hospital
Division name	operating room
Address	3-1-1 maedashi higashi-ku, Fukuoka Japan maedashi higashi-ku, Fukuoka Japan
TEL	092-642-5714
Email	shiron@kuaccm.med.kyushu-u.ac.jp

Public contact
Name of contact person	Kazuhiro Shirozu
Organization	Kyushu university hospital
Division name	operating room
Address	3-1-1 maedashi higashi-ku, Fukuoka Japan-1-1 maedashi higashi-ku, Fukuoka Japan
TEL	092-642-5714
Homepage URL
Email	shiron@kuaccm.med.kyushu-u.ac.jp

Sponsor
Institute	Department of anesthesia in Kyushu University
Institute
Department

Funding Source
Organization	non
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	2015 Year 11 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 24 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	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This prospective cohort study involved patients who underwent open heart surgery with CPB at our University Hospital from January 2016. Patients with blood diseases were excluded.

Management information
Registered date	2015 Year 11 Month 09 Day
Last modified on	2017 Year 11 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022771