UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	the analysis of blood coagulation and platelet function during hypothermia or normal temperature extracorporeal circulation
Title of the study (Brief title)	the analysis of blood coagulation and platelet function during hypothermia or normal temperature extracorporeal circulation
Region	Japan

Condition
Condition	the patients proposed to perform cardiovascular surgery
Classification by specialty	Vascular surgery Cardiovascular surgery Operative medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	the comparison of blood coagulation and platelet function during hypothermia extracorporeal circulation with normal temperature
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the value of blood coagulation and platelet function during hypothermia or normal temperature extracorporeal circulation (at the admission of extracorporeal circulation, and every 45 minetes after the admission of it), the correlation of standard blood analysis at 45 minutes after the admission of extracorporeal circulation
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	normal temperature extracorporeal circulation group (from one day before operation to operation day)
Interventions/Control_2	hypothermia extracorporeal circulation group (from one day before operation to operation day)
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	the patients proposed to perform cardiovascular surgery under extracorporeal circulation
Key exclusion criteria	the patients who has difficulty in mutual understanding and has difficulty to get cooperation
Target sample size	50

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, Chuo-ku, Sapporo
TEL	011-688-9663
Email	edanaka@sapmed.ac.jp

Public contact
Name of contact person	Hiroshi Takeda
Organization	Sapporo Medical University School of Medicine
Division name	Hospital secction
Address	S1, W16, Chuo-ku, Sapporo
TEL	011-611-2111
Homepage URL
Email	hiroshi.takeda@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	2016 Year 03 Month 21 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 12 Month 16 Day
Anticipated trial start date	2016 Year 03 Month 22 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	2016 Year 03 Month 19 Day
Last modified on	2018 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024844