UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032224 |
|---|---|
| Receipt number | R000036746 |
| Scientific Title | Prediction of in-circuit coagulation using blood coagulation analyzer in continuous renal replacement therapy |
| Date of disclosure of the study information | 2018/04/13 |
| Last modified on | 2018/04/12 22:29:10 |
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Basic information
Public title
Prediction of in-circuit coagulation using blood coagulation analyzer in continuous renal replacement therapy
Acronym
Prediction of in-circuit coagulation using blood coagulation analyzer in CRRT
Scientific Title
Prediction of in-circuit coagulation using blood coagulation analyzer in continuous renal replacement therapy
Scientific Title:Acronym
Prediction of in-circuit coagulation using blood coagulation analyzer in CRRT
Region
| Japan |
Condition
Condition
critically ill patient
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will retrospectively investigate whether the blood coagulation analyzer "ROTEM" which can measure blood coagulation and fibrinolysis easily and quickly is a device capable of predicting in-circuit coagulation at CRRT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between ROTEM parameter and in-circuit coagulation
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients in which ROTEM was measured at our hospital ICU and CRRT was performed
Key exclusion criteria
none
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroomi Tatsumi |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Intensive Care Medicine
Zip code
Address
South 1 West 16, Chuo-ku, Sapporo, Japan
TEL
011-611-2111
htatsumi@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroomi Tatsumi |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Intensive Care Medicine
Zip code
Address
South 1 West 16, Chuo-ku, Sapporo, Japan
TEL
011-611-2111
Homepage URL
http://sapmedicu.com/research.html
htatsumi@sapmed.ac.jp
Sponsor or person
Institute
Department of Intensive Care Medicine, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Intensive Care Medicine, Sapporo Medical 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
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
| 2018 | Year | 04 | Month | 13 | Day |
Related information
URL releasing protocol
http://sapmedicu.com/research.html
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Of the ROTEM parameters, INTEM-CT, EXTEM-alfa angle, EXTEM-MCF were shown to be effective for predicting in-circuit coagulation.
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
Main results already published
Date of protocol fixation
| 2018 | Year | 01 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We compared general blood test values (ACT, platelet count, fibrinogen, FDP) and ROTEM parameters.
Management information
Registered date
| 2018 | Year | 04 | Month | 12 | Day |
Last modified on
| 2018 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036746
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
