UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045045 |
|---|---|
| Receipt number | R000051452 |
| Scientific Title | Developement of the score predicting postoperative hemorrhage in the patients undergoing antithrombotic therapy |
| Date of disclosure of the study information | 2021/08/02 |
| Last modified on | 2023/02/02 11:37:27 |
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Basic information
Public title
Developement of the score predicting postoperative hemorrhage in the patients undergoing antithrombotic therapy
Acronym
Tooth extraction of the patients undergoing antithrombotic therapy
Scientific Title
Developement of the score predicting postoperative hemorrhage in the patients undergoing antithrombotic therapy
Scientific Title:Acronym
Tooth extraction of the patients undergoing antithrombotic therapy
Region
| Japan |
Condition
Condition
antithrombotic therapy
Classification by specialty
| Cardiology | Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For patients undergoing antithrombotic therapy, the prediction of post-extraction bleeding will be examined in a retrospective observational study using existing information.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence or absence of bleeding after tooth extraction and incidence rate
Key secondary outcomes
1) Blood test values and disease names of patients who have bleeding after tooth extraction
2) Development of predictive score for post-extraction bleeding equivalent to HAS-BLED score
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
| 1 | days-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients underwent tooth extraction on antithrombotic therapy
Key exclusion criteria
The patients without antithrombotic therapy
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Yoshinari |
| Middle name | |
| Last name | Morimoto |
Organization
Kanagawa Dental University (National Cardiovascular Center)
Division name
Department of of Critical Care Dentistry (Department of Dentistry)
Zip code
238-8580
Address
82, Inaoka-cho, Yokosuka, Kanagawa, 238-8580, Japan (1-6, Kishibe-shinmachi, Suita, Osaka, 564-8565)
TEL
046-845-3168
morimoto@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinari |
| Middle name | |
| Last name | Morimoto |
Organization
Kanagawa Dental University (National Cardiovascular Center)
Division name
Department of of Critical Care Dentistry (Department of Dentistry)
Zip code
238-8580
Address
82, Inaoka-cho, Yokosuka, Kanagawa, 238-8580, Japan (1-6, Kishibe-shinmachi, Suita, Osaka, 564-8565)
TEL
046-845-3168
Homepage URL
morimoto@kdu.ac.jp
Sponsor or person
Institute
Department of Dentistry, National cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Dental University (National Cardiovascular Center)
Address
82, Inaoka-cho, Yokosuka, Kanagawa, 238-8580, Japan (1-6, Kishibe-shinmachi, Suita, Osaka, 564-8565)
Tel
046-845-3168
morimoto@kdu.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
| 2021 | Year | 08 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 11 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
1. Patient information
Name, gender, age (date of birth), ID number, disease name, medication, ventricular assist device (VAD) insertion date, ventricular assist device (VAD) type and setting (most recent dental procedure), echocardiographic findings (each) The latest dental procedure)
2. Information about dentistry
Date of dental treatment, name of dental disease, treatment content (simple tooth extraction, surgical tooth extraction, other oral surgery, periodontal treatment, prosthetic treatment, conservative treatment, preventive treatment), number of treated teeth, presence or absence of post-bleeding And content (days after surgery, additional treatment, course, outcome)
3. Blood test value
Blood test value immediately before each dental procedure
eGFR, TP, ALB, Bil (Direct), AST, ALT, ALP, gGTP, ChE, LD, CK, BUN, Crea, FBS, CRP, CKMB, WBC, RBC, Hb, Ht, PLT, WBC fraction (Neut) , Lymph, Mono, Eosino, Baso, MPV), BNP, ANP
Inspection values 5 times before and 5 times after tooth extraction
APTT, Fibrinogen, AT activity, FDP, D-dimer, PT (%), PT-INR
Management information
Registered date
| 2021 | Year | 08 | Month | 02 | Day |
Last modified on
| 2023 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051452
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