UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029081 |
|---|---|
| Receipt number | 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 11:43:37 |
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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
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
midoyee@gmail.com
Sponsor or person
Institute
Korea University Guro Hospital
Department of Anesthesiology and Pain Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
Single case data URL
Value
https://center6.umin.ac.jp/ice/33261
