UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019046 |
|---|---|
| Receipt number | R000021920 |
| Scientific Title | Multicenter study of postoperative hemorrhage after oral surgery in patients receiving anticoagulation therapy |
| Date of disclosure of the study information | 2015/09/16 |
| Last modified on | 2016/03/16 10:01:48 |
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Basic information
Public title
Multicenter study of postoperative hemorrhage after oral surgery in patients receiving anticoagulation therapy
Acronym
Multicenter study of postoperative hemorrhage after oral surgery in patients receiving anticoagulation therapy
Scientific Title
Multicenter study of postoperative hemorrhage after oral surgery in patients receiving anticoagulation therapy
Scientific Title:Acronym
Multicenter study of postoperative hemorrhage after oral surgery in patients receiving anticoagulation therapy
Region
| Japan |
Condition
Condition
Patients receiving antithorombotic therapy
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluatetion of postoperative hemorrhage after tooth extraction in patients receiving antithrombotic therapy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of postoperative hemorrhage after tooth extraction
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients receiving antithoronbotic therapy
Key exclusion criteria
insuficient medical records
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Umeda |
Organization
Nagasaki University Hospital
Division name
Department of Oral and Maxillofacial Surgery
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7698
mumeda@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Souichi Yanamoto |
Organization
Nagasaki University Hospital
Division name
Department of Oral and Maxillofacial Surgery
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7698
Homepage URL
syana@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
Organization
Division
Category of Funding Organization
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
| 2015 | Year | 09 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Multicenter retrospective observation study.
It was admitted to the participating institutions until March 31, 2016 from the date of approval, and the anti-thrombotic therapy patients undergoing tooth extraction target. Survey items, age, sex, underlying disease, type of antithrombotic drugs, medical history (diabetes, hypertension, cerebrovascular disease, bleeding complications, liver disease, kidney disease), smoking, alcohol dependence, the contents of the local hemostasis , blood test data, antimicrobial drugs or NSAIDs taken of the presence or absence and type of pre-treatment, it will be with the presence or absence of post-bleeding.
Management information
Registered date
| 2015 | Year | 09 | Month | 16 | Day |
Last modified on
| 2016 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021920
