UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011232 |
|---|---|
| Receipt number | R000012827 |
| Scientific Title | Platelet function assay and the discontinuance time of aspirin and clopidogrel before surgery |
| Date of disclosure of the study information | 2013/07/31 |
| Last modified on | 2014/04/28 10:12:20 |
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Basic information
Public title
Platelet function assay and the discontinuance time of aspirin and clopidogrel before surgery
Acronym
preoperative platelet function assay with aspirin and clopidogrel
Scientific Title
Platelet function assay and the discontinuance time of aspirin and clopidogrel before surgery
Scientific Title:Acronym
preoperative platelet function assay with aspirin and clopidogrel
Region
| Asia(except Japan) |
Condition
Condition
before undergoing elective surgery under general anesthesia
Classification by specialty
| Hematology and clinical oncology | Anesthesiology | Laboratory medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
compare platelet function test using PFA-100 with col/EPI cartiridge by their own antiplatelet therapy(only aspirin vs aspirin plus clopidogrel) and the periods of antiplatelet discontinuation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
There was a significant decrease in PFA value when the periods of antiplatelet discontinuation exceed seven days, not five days
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
| 35 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with an ASA physical status I-II who were gone off within 30 days or maintained their own antiplatelet therapy (only aspirin 100mg per day or aspirin 100mg per day plus clopidogrel 75mg per day) before undergoing elective surgery under general anesthesia
Key exclusion criteria
patients with severe systemic disease, a hypovolemic state, congenital platelet disorder, known history of aspirin resistance, or who were being treated with other anticoagulants or herbal medications
Target sample size
188
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Il-Ok Lee |
Organization
Korea University
Division name
Anesthesiology and Pain Medicine
Zip code
Address
Gurodong-ro 148, Guro-gu, Seoul, Republic of Korea
TEL
82-2-2626-1437
iloklee@korea.ac.kr
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Il-Ok Lee |
Organization
Korea University
Division name
Anesthesiology and Pain Medicine
Zip code
Address
Gurodong-ro 148, Guro-gu, Seoul, Republic of Korea
TEL
82-2-2626-1437
Homepage URL
iloklee@korea.ac.kr
Sponsor or person
Institute
Korea University
Institute
Department
Personal name
Funding Source
Organization
Korea University
Organization
Division
Category of Funding Organization
Outside Japan
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
| 2013 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 06 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 03 | Day |
Date of closure to data entry
| 2014 | Year | 01 | Month | 06 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 06 | Day |
Date analysis concluded
| 2014 | Year | 01 | Month | 06 | Day |
Other
Other related information
PFAs are determined on the morning of the day of surgery. we assess the difference of the groups classified by their own antiplatelet therapy (aspirin only or aspirin+clopidogrel) and the periods of antiplatelet discontinuation.
A receiver operating characteristic (ROC) analysis and the area under the curve (AUC) was achieved by logistic regression to evaluate the logistic predicted probability and the performance of classification by the periods of antiplatelet discontinuation.
Management information
Registered date
| 2013 | Year | 07 | Month | 19 | Day |
Last modified on
| 2014 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012827
