UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037183 |
|---|---|
| Receipt number | R000042375 |
| Scientific Title | monitoring of blood coagulation and platelet function by using TEG6s during and after discontinuation of anti-platelet and DOAC |
| Date of disclosure of the study information | 2019/06/27 |
| Last modified on | 2023/06/29 09:41:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
monitoring of blood coagulation and platelet function by using TEG6s during and after discontinuation of anti-platelet and new oral anticoagulant
Acronym
monitoring of blood coagulation and platelet function by using TEG6s during and after discontinuation of anti-platelet and new oral anticoagulant
Scientific Title
monitoring of blood coagulation and platelet function by using TEG6s during and after discontinuation of anti-platelet and DOAC
Scientific Title:Acronym
monitoring of blood coagulation and platelet function by using TEG6s during and after discontinuation of anti-platelet and DOAC
Region
| Japan |
Condition
Condition
patients medicated anti-platelet and DOAC
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure blood coagulation and platelet function by using TEG6s during and discontinuation of anti-platelet and DOAC for patients 65 years old or more.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes in characteristics of blood coagulation during and after discontinuation of DOAC
The changes in platelet function during and after discontinuation of anti-platelet
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients scheduled to operation, and medicated and discontinued anti-platelet and DOAC
Key exclusion criteria
patients without cooperation or disagreed from patients family
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mitsutaka |
| Middle name | |
| Last name | Edanaga |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
060-8543
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-688-9663
edanaka@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Kouji |
| Middle name | |
| Last name | Hamaya |
Organization
Sapporo Medical University School of Medicine
Division name
Hospital section
Zip code
060-8543
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
ko-hamaya-923@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University School of Medicine
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University School of Medicine
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
Tel
011-611-2111
ko-hamaya-923@sapmed.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
| 2019 | Year | 06 | Month | 27 | 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
| 2019 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We are going to measure blood coagulation or platelet function by using TEG6s at admission of operating room and before operation end
Management information
Registered date
| 2019 | Year | 06 | Month | 26 | Day |
Last modified on
| 2023 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042375
