UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	the evaluation of coagulation function and platelet function after having stopped to use anti-platelet drug or anti-coagulant drug
Title of the study (Brief title)	the evaluation of coagulation function and platelet function after having stopped to use anti-platelet drug or anti-coagulant drug
Region	Japan

Condition
Condition	the patients whom schedulled to proposed operation or emergent operation
Classification by specialty	Ophthalmology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We would like to evaluate qualitative valiation of coagulation function and platelet function afeter having stopped to use anti-platelet drug or anti-coagulant drug in perioperative period
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the data to obtain by Sonoclot®, the correlation between the preoperative value of blood test and the postoperative that, and the validity of in-hospital standard for stopping to use anti-platelet or anti-coagulant drug
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Sonoclot which be able to measure coagulation function and platelet function intervention period is one day
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	15 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	the patients from 15 to 89 years old, whom schedulled to proposed operation or emergent operation and stopped to use anti-platelet or anti-coagulant drug
Key exclusion criteria	examinee whom has no agreement or has declinature examiee whom doctors confirmed to stop the administration of the study
Target sample size	100

Research contact person
Name of lead principal investigator	Mitsutaka Edanaga
Organization	Sapporo Medical University School of Medicine
Division name	Department of Anesthesiology
Address	S1,W16 chu-oku, Sapporo, Hokkaido, Japan
TEL	011-611-2111
Email	edanaka@sapmed.ac.jp

Public contact
Name of contact person	Kazuhiro Nakane
Organization	Sapporo Medical University School of Medicine
Division name	Hospital Division
Address	S1,W16 chu-oku, Sapporo, Hokkaido, Japan
TEL	011-611-2111
Homepage URL
Email	akifujito@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization	Department of Anesthesiology, Sapporo Medical University School of Medicine
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 04 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 18 Day
Anticipated trial start date	2015 Year 04 Month 13 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

Management information
Registered date	2015 Year 04 Month 08 Day
Last modified on	2018 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019806