UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A retrospective study of relation between change in blood coagulation and fibrinogenolysis system and bleeding even in perioperative period of cardiovascular surgery
Title of the study (Brief title)	A retrospective study of relation between change in blood coagulation and fibrinogenolysis system and bleeding even in perioperative period of cardiovascular surgery
Region	Japan

Condition
Condition	Patients who have undergone cardiovascular surgery
Classification by specialty	Hematology and clinical oncology Vascular surgery Anesthesiology Cardiovascular surgery Blood transfusion
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate relation between change in blood coagulation and fibrinogenolysis system and bleeding even in perioperative period of cardiovascular surgery
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relation between bleeding volume and coagulation-fibrinogenolysis laboratory findings
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	Patients who underwent cardiovascular surgery from 1/Jan/2011 to 31/Aug/2015 in Fukuoka university hospital
Key exclusion criteria	N/A
Target sample size	100

Research contact person
Name of lead principal investigator	Ken Yamaura
Organization	Fukuoka University Hospital
Division name	Department of Anesthesiology
Address	7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan
TEL	092-801-1011
Email	keny@fukuoka-u.ac.jp

Public contact
Name of contact person	Go Kusumoto
Organization	Fukuoka University Hospital
Division name	Department of Anesthesiology
Address	7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan
TEL	092-801-1011
Homepage URL
Email	kusumoto@fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University Hospital
Institute
Department

Funding Source
Organization	None
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 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 07 Day
Anticipated trial start date	2015 Year 11 Month 27 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	Retrospective chart reviews

Management information
Registered date	2015 Year 11 Month 27 Day
Last modified on	2017 Year 03 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023034