UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047541 |
|---|---|
| Receipt number | R000054218 |
| Scientific Title | The relationship between fibrinogen levels and platelet counts at the point of care with the Quantra QPlus for patients using cardiopulmonary bypass |
| Date of disclosure of the study information | 2022/04/20 |
| Last modified on | 2022/04/20 20:27:39 |
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Basic information
Public title
The relationship between fibrinogen levels and platelet counts at the point of care with the Quantra QPlus for patients using cardiopulmonary bypass
Acronym
The relationship between fibrinogen levels and platelet counts at the point of care with the Quantra QPlus
Scientific Title
The relationship between fibrinogen levels and platelet counts at the point of care with the Quantra QPlus for patients using cardiopulmonary bypass
Scientific Title:Acronym
The relationship between fibrinogen levels and platelet counts at the point of care with the Quantra QPlus for patients using cardiopulmonary bypass
Region
| Japan |
Condition
Condition
Patients who receive cardiac surgery
Classification by specialty
| Anesthesiology | Cardiovascular surgery | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Use quantra to determine if it accurately predicts fibrinogen levels and platelet counts as measured by central testing
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparing fibrinogen level and platelet counts using point of care viscoelastic device and the other tests.
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
cases of cardiac surgery using CPB
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | shingo |
| Middle name | |
| Last name | kawashima |
Organization
Hamamatsu Medical University of School
Division name
Department of Anesthesiology and Intensive Care
Zip code
4313192
Address
1-20-1 Handayama Higashi-ku Hamamatsu city
TEL
053-435-2286
shingogo@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | shingo |
| Middle name | |
| Last name | kawashima |
Organization
Hamamatsu Medical University of School
Division name
Department of Anesthesiology and Intensive Care
Zip code
Hamamatsu Medical University of School
Address
1-20-1 Handayama Higashi-ku Hamamatsu city
TEL
053-435-2286
Homepage URL
shingogo@hama-med.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Intensive Care, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology and Intensive Care, Hamamatsu University School of Medicine
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
Hamamatsu University School of Medicine
Address
1-20-1 Handayama Higashi-ku Hamamatsu city
Tel
0534352111
shingogo@hama-med.ac.jp
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
| 2022 | Year | 04 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 04 | Month | 20 | Day |
Last modified on
| 2022 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054218
