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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000021547
Receipt No. R000024844
Scientific Title the analysis of blood coagulation and platelet function during hypothermia or normal temperature extracorporeal circulation
Date of disclosure of the study information 2016/03/21
Last modified on 2018/12/10

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Basic information
Public title the analysis of blood coagulation and platelet function during hypothermia or normal temperature extracorporeal circulation
Acronym the analysis of blood coagulation and platelet function during hypothermia or normal temperature extracorporeal circulation
Scientific Title the analysis of blood coagulation and platelet function during hypothermia or normal temperature extracorporeal circulation
Scientific Title:Acronym 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
1st name
Middle name
Last name Mitsutaka Edanaga
Organization Sapporo Medical University School of Medicine
Division name Department of Anesthesiology
Zip code
Address S1, W16, Chuo-ku, Sapporo
TEL 011-688-9663
Email edanaka@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Takeda
Organization Sapporo Medical University School of Medicine
Division name Hospital secction
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2015 Year 12 Month 16 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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