UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019726 |
|---|---|
| Receipt number | R000022782 |
| Scientific Title | Coaglation and fibrinolytic function in use of intraoperative blood salvage for cardiovasucular surgery |
| Date of disclosure of the study information | 2015/11/10 |
| Last modified on | 2018/05/31 05:30:59 |
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Basic information
Public title
Coaglation and fibrinolytic function in use of intraoperative blood salvage for cardiovasucular surgery
Acronym
Blood salvage and coagulation function
Scientific Title
Coaglation and fibrinolytic function in use of intraoperative blood salvage for cardiovasucular surgery
Scientific Title:Acronym
Blood salvage and coagulation function
Region
| Japan |
Condition
Condition
patients undergoing cardiovascular surgeries
Classification by specialty
| Anesthesiology | Cardiovascular surgery | Blood transfusion |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore mechanisms of coagulation dysfunction in blood salvage in vitro preparation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fibtem MCF (maximum Clot Firmness) obtained from thoromboelastometry
Key secondary outcomes
Extem MCF and CT obtained form thoronboelastometry
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients undergoing scheduled cardiovascular surgeries
2. Patients prepared for use of blood slvage
Key exclusion criteria
1. Patients undergoing emergency surgeries
2. Patients with hematologic diseases
3. Patients with contraindication for use of heparin
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Son Kyongsuk |
Organization
Chiba University Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-8-1 Inohana-cho, Chuo-ku, Chiba
TEL
043-222-7171
kyong0203suk@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Son Kyongsuk |
Organization
Chiba University Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-8-1 Inohana-cho, Chuo-ku, Chiba
TEL
043-222-7171
Homepage URL
kyong0203suk@yahoo.co.jp
Sponsor or person
Institute
Department of Anesthesiology, Chiba University Hosppital
Institute
Department
Personal name
Funding Source
Organization
Institutional
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
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 | 11 | Month | 10 | 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
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
By using thoromboelastometry, we plan to exlore presence of does dependence of coagulation dysfunction and determine independent factors for the coagulation dysfunction. When the investigators work in the operating room, the first 65 patients fulfilling the inclusion criteria will be studied during the study period.
Management information
Registered date
| 2015 | Year | 11 | Month | 10 | Day |
Last modified on
| 2018 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022782
