UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027293 |
|---|---|
| Receipt number | R000031274 |
| Scientific Title | Analysis of Hemostasisarrest of Bleeding for Patients with Direct Oral Anti-Coagulant after Tooth Extraction Based on the Duration of DOAC Administration and Serum Concentration |
| Date of disclosure of the study information | 2017/08/24 |
| Last modified on | 2022/01/04 16:49:18 |
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Basic information
Public title
Analysis of Hemostasisarrest of Bleeding for Patients with Direct Oral Anti-Coagulant after Tooth Extraction Based on the Duration of DOAC Administration and Serum Concentration
Acronym
Analysis of Hemostasisarrest of Bleeding for Patients with Direct Oral Anti-Coagulant after Tooth Extraction
Scientific Title
Analysis of Hemostasisarrest of Bleeding for Patients with Direct Oral Anti-Coagulant after Tooth Extraction Based on the Duration of DOAC Administration and Serum Concentration
Scientific Title:Acronym
Analysis of Hemostasisarrest of Bleeding for Patients with Direct Oral Anti-Coagulant after Tooth Extraction
Region
| Japan |
Condition
Condition
over 65 years-old prevalence elderly
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to establish treatment plan for dental extraction for patients with monitoring hemostasisarrest of bleeding, DOAC plasma concentration, PT and APTT after DOAC administration.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis of bleeding
We will evaluate 0-4 grades as follows.
0:No bleeding is detected from the site of tooth extraction before suture.
1:No bleeding is detected from the site of tooth extraction after suture.
2:No bleeding is detected from the site of tooth extraction after 5 min pressure homostasis after suture.
3:Bleeding is detected from the site of tooth extraction after 5 min pressure homostasis.
Key secondary outcomes
Serum concentration of DOAC, PT, APTT
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Control of duration from the administration of DOAC to the start of extraction
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
1.The patients who have medical examination in Tokyo Medical and Dental University of special care 1 department
2. The patients who are electively undergo teeth extraction
3. The patients with ASA PS 2-3
4. The patients who can subscribe to informed consent
Key exclusion criteria
The patients with two types of anticoagulants
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Minakuchi |
Organization
Tokyo Medical and Dental University
Division name
Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences
Zip code
113-8549
Address
1-5-45 Yushima,Bunkyo-ku,Tokyo
TEL
03-5803-5582
s.minakuchi.gerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kazumasa |
| Middle name | |
| Last name | Kubota |
Organization
Tokyo Medical and Dental University
Division name
Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate Schoo
Zip code
113-8549
Address
1-5-45 Yushima,Bunkyo-ku,Tokyo
TEL
03-5803-4560
Homepage URL
kuboanph@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
None
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
Tokyo Medical and Dental University
Address
1-5-45 Bunkyo-ku Yushima, Tokyo Japan
Tel
03-5803-4056
office.innv@tmd.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
| 2017 | Year | 08 | Month | 24 | 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
0
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
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 10 | Day |
Last modified on
| 2022 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031274
