UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025157 |
|---|---|
| Receipt number | R000028939 |
| Scientific Title | Coaglation and fibrinolytic function in use of intraoperative blood salvage for cardiovasucular surgery/Comparative test with other infusion |
| Date of disclosure of the study information | 2016/12/09 |
| Last modified on | 2021/04/17 20:50:59 |
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Basic information
Public title
Coaglation and fibrinolytic function in
use of intraoperative blood salvage for
cardiovasucular surgery/Comparative test with other infusion
Acronym
Comparinson between intraoperative cell salvage and other infusion
Scientific Title
Coaglation and fibrinolytic function in
use of intraoperative blood salvage for
cardiovasucular surgery/Comparative test with other infusion
Scientific Title:Acronym
Comparinson between intraoperative cell salvage and other infusion
Region
| Japan |
Condition
Condition
patients undergoing cardiovascular sur
geries
Classification by specialty
| Anesthesiology | Cardiovascular surgery | Blood transfusion |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the coagulation / fibrinolysis system when intraoperative cell salvage blood is administered using thromboelastography and investigate the difference from infusion preparation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FIBTEM Maximum clot firmness
Key secondary outcomes
EXTEM MCF (Maximum clot firmness)
INTEM CT (clotting time)
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
adult
cardiovascular surgery
Key exclusion criteria
Coagulo-fibrinolytic Abnormalities
allergy of heparin
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyongsuk Son |
Organization
Chiba university hospital
Division name
Anesthesiology
Zip code
Address
1-8-1inohana chuuou-ku
TEL
0432227171
aeha4928@chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyongsuk Son |
Organization
Chiba university hospital
Division name
Anesthesiology
Zip code
Address
1-8-1inohana chuuou-ku
TEL
0432227171
Homepage URL
aeha4928@chiba-u.jp
Sponsor or person
Institute
Chiba university hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba university hospital
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
| 2016 | Year | 12 | Month | 09 | 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
| 2016 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Intraoperative cell salvage blood and patient blood are mixed and examined using thromboelastography. We will also investigate similar cases using infusion formulations ( saline,colloid)
Management information
Registered date
| 2016 | Year | 12 | Month | 06 | Day |
Last modified on
| 2021 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028939
