UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050947 |
|---|---|
| Receipt number | R000058000 |
| Scientific Title | Perioperative hemostatic monitoring during TAVI procedures using thromboelastography |
| Date of disclosure of the study information | 2023/04/28 |
| Last modified on | 2026/04/30 09:27:00 |
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Basic information
Public title
Perioperative hemostatic monitoring during TAVI procedures using thromboelastography
Acronym
Perioperative hemostatic monitoring during TAVI procedures
Scientific Title
Perioperative hemostatic monitoring during TAVI procedures using thromboelastography
Scientific Title:Acronym
Perioperative hemostatic monitoring during TAVI procedures
Region
| Japan |
Condition
Condition
severe aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the patient's coagulation and hemostasis ability using thromboelastography, and to clarify the changes in the coagulation and hemostasis function during the perioperative period of TAVI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of change in coagulation and hemostasis ability using thromboelastography after TAVI surgery
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing transcatheter aortic valve transplantation for aortic stenosis
Key exclusion criteria
Patients who declared non-participation in the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasutaka |
| Middle name | |
| Last name | Yamada |
Organization
Department of Anesthesiology and Critical Care Medicine, Faculty of Medicine, Saga University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
849-8501
Address
5-1-1, Nabeshima, Saga City, Saga
TEL
0952-34-3370
sj8919@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasutaka |
| Middle name | |
| Last name | Yamada |
Organization
Department of Anesthesiology and Critical Care Medicine, Faculty of Medicine, Saga University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
849-8501
Address
5-1-1, Nabeshima, Saga City, Saga
TEL
0952-34-3370
Homepage URL
sj8919@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Anesthesiology and Critical Care Medicine, Faculty of Medicine, Saga University
Address
5-1-1, Nabeshima, Saga City, Saga
Tel
0952-34-3370
sj8919@cc.saga-u.ac.jp
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 | 04 | Month | 28 | Day |
Related information
URL releasing protocol
https://chiken.med.saga-u.ac.jp/clinical-disclosure/89.html
Publication of results
Partially published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/browse/jtvt/-char/en
Number of participants that the trial has enrolled
30
Results
The patients had a mean age of 83.9 years. Platelet counts and hemoglobin levels decreased over time (p = 0.038, 0.0002). MA, which represents maximum clot strength, showed no significant difference among the CK, CRT, CKH, or CFF parameters (all 3 points). CRT R and CKH R were prolonged immediately after surgery (p = 0.02, p = 0.001) but shortened by the day after surgery (p = 0.014, p = 0.001). CK R and CK K showed shortening on the day after surgery (p = 0.0001, p = 0.03).
Results date posted
| 2026 | Year | 04 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We conducted a prospective observational study of 30 TAVI procedures performed at our hospital between September 2023 and March 2024.
Participant flow
TEG Global Hemostasis was measured at three time points preoperative, immediately postoperative, and the day after surgery and changes in R (reaction time, clotting time), K (kinetics, rate of clot formation), MA (maximum amplitude, maximum clot strength), and LY (lysis, lysis) were compared for the CK, CRT, CKH, and CFF parameters. We also compared the trends in Hb, platelet count, Fib, PT, and APTT activity.
Adverse events
none
Outcome measures
TEG Global Hemostasis was measured at three time points preoperative, immediately postoperative, and the day after surgery and changes in R (reaction time, clotting time), K (kinetics, rate of clot formation), MA (maximum amplitude, maximum clot strength), and LY (lysis, lysis) were compared for the CK, CRT, CKH, and CFF parameters. We also compared the trends in Hb, platelet count, Fib, PT, and APTT activity.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Monitor changes in coagulation and hemostasis ability using thromboelastography immediately before, immediately after, and the day after TAVI surgery, and clarify changes in coagulation and hemostasis ability during the TAVI perioperative period.
Management information
Registered date
| 2023 | Year | 04 | Month | 28 | Day |
Last modified on
| 2026 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058000
