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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010866
Receipt No. R000012663
Scientific Title Clinical evaluation on activation of coagulation and fibrinolytic system during major cardiovascular surgery
Date of disclosure of the study information 2013/06/17
Last modified on 2016/07/07

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Basic information
Public title Clinical evaluation on activation of coagulation and fibrinolytic system during major cardiovascular surgery
Acronym Clinical evaluation on activation of coagulation and fibrinolytic system during major cardiovascular surgery
Scientific Title Clinical evaluation on activation of coagulation and fibrinolytic system during major cardiovascular surgery
Scientific Title:Acronym Clinical evaluation on activation of coagulation and fibrinolytic system during major cardiovascular surgery
Region
Japan

Condition
Condition major cardiovascular surgery with use of cardiopulmonary bypass
Classification by specialty
Anesthesiology Cardiovascular surgery Blood transfusion
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate the activation of coagulation and fibrinolytic pathway during cardiopulmonary bypass in aortic replacement surgery in comparison with other cardiopulmonary surgery
Basic objectives2 Others
Basic objectives -Others observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes activated factor VII, thrombin-antithrombin complex (TAT), fibrin monomer, fibrin degradation product (FDP), D-dimer, plasmin-plasmin inhibitor complex (PIC), fibrinogen, PT, APTT, platelet count, hemoglobin, from just before the start of cardiopulmonary bypass until entrance into the intensive care unit
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria aortic replacement surgery,other cardiovascular surgery,re-surgery for cardiovascular replacement
Key exclusion criteria patients with congenital bleeding diathesis, patients with thrombocytopenia less than 100,000/uL continuing more than one month, patients with taking oral anticoagulant/antiplatelet agents
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name SATO HIDEO
Organization Teikyo University Hospital
Division name anesthesiology
Zip code
Address 2-11-1 Kaga,Itabashi-ku,Tokyo 173-8605 JAPAN
TEL 03-3964-1211
Email hideos3150@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name SATO HIDEO
Organization Teikyo University Hospital
Division name anesthesiology
Zip code
Address 2-11-1 Kaga,Itabashi-ku,Tokyo 173-8605 JAPAN
TEL 03-3964-1211
Homepage URL
Email hideos3150@yahoo.co.jp

Sponsor
Institute Teikyo University Hospital
Institute
Department

Funding Source
Organization Teikyo University Hospital
department of anesthesiology
Organization
Division
Category of Funding Organization Other
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
2013 Year 06 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2013 Year 04 Month 13 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate the activation of coagulation and fibrinolytic pathway during cardiopulmonary bypass in aortic replacement surgery in comparison with other cardiovascular surgery

prospective study

Management information
Registered date
2013 Year 06 Month 04 Day
Last modified on
2016 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012663

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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