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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029081
Receipt No. R000033261
Scientific Title An in vitro investigation of coagulation effects of exogenous sugammadex using thromboelastography in orthopaedic surgical patients .
Date of disclosure of the study information 2017/09/11
Last modified on 2018/02/21

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Basic information
Public title An in vitro investigation of coagulation effects of exogenous sugammadex using thromboelastography in orthopaedic surgical patients .
Acronym An in vitro investigation of coagulation effects of sugammadex using thromboelastography
Scientific Title An in vitro investigation of coagulation effects of exogenous sugammadex using thromboelastography in orthopaedic surgical patients .
Scientific Title:Acronym An in vitro investigation of coagulation effects of sugammadex using thromboelastography
Region
Asia(except Japan)

Condition
Condition Coagulation effects of sugammadex
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate of coagualtion effects of exogenous sugammadex in surgical patients
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Thromboelastography parameters for citrated whole blood and citrated whole blood with exogenous sugammadex
Key secondary outcomes Association between percent change of thromboelastography parameters and sugammadex concentration

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
19 years-old <=
Age-upper limit
45 years-old >
Gender Male and Female
Key inclusion criteria American Society of Anesthesiologist Physical Class 1-2
Orthopaedic surgery patient
Key exclusion criteria Patients taking aspirin or oral anticoagulant within 14 days
Platelet<100,000, PT INR>1.5, or aPTT>50 sec
Pregnant woman
Liver disease or renal disease
Surgical history within 30 days
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hae Wone Chang
Organization Korea University Guro Hospital
Division name Anesthesiology and Pain Medicine
Zip code
Address 148 Gurodong-ro, Guro-gu, Seoul
TEL 82226263237
Email chelenh@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Mido Lee
Organization Korea University Guro Hospital
Division name Anesthesiology and Pain Medicine
Zip code
Address 148 Gurodong-ro, Guro-gu, Seoul
TEL 82226261437
Homepage URL
Email midoyee@gmail.com

Sponsor
Institute Korea University Guro Hospital
Department of Anesthesiology and Pain Medicine
Institute
Department

Funding Source
Organization Korea University Guro Hospital
Department of Anesthesiology and Pain Medicine
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
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 Korea University Guro Hospital (Seoul)

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 11 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
Increased sugammadex concentrations were significantly associated with reduced coagulation, as evidenced by the increases in reaction time (r), coagulation time, and time to maximum rate of thrombus generation (TMRTG), and the decreases in the angle, maximum amplitude, and maximum rate of thrombus generation. Compared with the control, the median percentage change (interquartile range) in the TEG values of the samples with the highest exogenous sugammadex concentration was the greatest for r, 53% (26%, 67.3%), and TMRTG, 48% (26%, 59%). 
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
2017 Year 09 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 12 Day
Last follow-up date
2017 Year 10 Month 01 Day
Date of closure to data entry
2017 Year 11 Month 29 Day
Date trial data considered complete
2017 Year 11 Month 29 Day
Date analysis concluded
2017 Year 11 Month 29 Day

Other
Other related information Thromboelastogrpahic parameters for citrated whole blood and citrated whole blood with exogenous sugammadex

Management information
Registered date
2017 Year 09 Month 11 Day
Last modified on
2018 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033261

Research Plan
Registered date File name
2017/11/29 Research Plan.docx

Research case data specifications
Registered date File name
2017/11/29 researchdataspecification.docx

Research case data
Registered date File name
2017/11/29 data_umin.xlsx


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