UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010866 |
|---|---|
| Receipt number | 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 05:25:21 |
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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
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
hideos3150@yahoo.co.jp
Sponsor or person
Institute
Teikyo University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012663
