UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051020 |
|---|---|
| Receipt number | R000058167 |
| Scientific Title | Evaluation of Thromboelasogrpahy (TEG) 6s for Predicting intra and postoperative bleeding in Geriatric Patients undergoing Hip Joint Surgery: Prospective Observational Study |
| Date of disclosure of the study information | 2023/05/09 |
| Last modified on | 2023/05/09 16:38:24 |
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Basic information
Public title
Evaluation of Thromboelasogrpahy (TEG) 6s for Predicting intra and postoperative bleeding in Geriatric Patients undergoing Hip Joint Surgery: Prospective Observational Study
Acronym
Evaluation of Thromboelasogrpahy (TEG) 6s
Scientific Title
Evaluation of Thromboelasogrpahy (TEG) 6s for Predicting intra and postoperative bleeding in Geriatric Patients undergoing Hip Joint Surgery: Prospective Observational Study
Scientific Title:Acronym
Evaluation of Thromboelasogrpahy (TEG) 6s
Region
| Asia(except Japan) |
Condition
Condition
Recruiting patient
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Association of TEG 6s value and intraoperative and postoperative blooding in patients undergoing hip joint surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Linear regression of CFF A10 and postoperative bleeding amount
Key secondary outcomes
Linear regression of CFF A10 and intraoperative bleeding
CFF MA AUC for detection massive bleeding
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who visited the orthopedic department of Eulji University Hospital, who were diagnosed with a femur fracture and decided to proceed with surgery, who received bipolar hemiarthroplasty with wiring, proximal femur long nail, open reduction and fixation.
It is intended for all patients undergoing general or spinal anesthesia. It is intended for patients 65 years of age or older, ASA 1-3, and patients scheduled to be admitted to the intensive care unit.
Key exclusion criteria
patients under 65 years of age, ASA 4 or higher, patients with a history of surgery within the last 30 days, and patients who refused to participate in the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | HAE WONE |
| Middle name | |
| Last name | CHANG |
Organization
Nowon Eulji University Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
01830
Address
68, Hangeulbiseok-ro, Nowon-gu, Seoul, Korea
TEL
82-2-970-8084
helen@eulji.ac.kr
Public contact
Name of contact person
| 1st name | Shin Wook |
| Middle name | |
| Last name | Lee |
Organization
Nowon Eulji University Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
01830
Address
68, Hangeulbiseok-ro, Nowon-gu, Seoul, Korea
TEL
82-2-970-8084
Homepage URL
chelenh@gmail.com
Sponsor or person
Institute
Nowon Eulji University Hospital
Institute
Department
Personal name
Nowon Hospital
Funding Source
Organization
Nowon Eulji University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
South Korea
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nowon Eulji University Hospital IRB
Address
68, Hangeulbiseok-ro, Nowon-gu, Seoul, Korea
Tel
82-2-9708707
younsonlee@eulji.ac.kr
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
| 2023 | Year | 05 | Month | 09 | 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
50
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
| 2020 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational
Management information
Registered date
| 2023 | Year | 05 | Month | 09 | Day |
Last modified on
| 2023 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058167
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
