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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011232
Receipt No. 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

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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
Email 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
Email iloklee@korea.ac.kr

Sponsor
Institute Korea University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012827

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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