UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043886 |
|---|---|
| Receipt number | R000050114 |
| Scientific Title | The prevention of venous thromboembolization following by using elastic bandage |
| Date of disclosure of the study information | 2021/04/12 |
| Last modified on | 2026/04/15 09:54:33 |
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Basic information
Public title
The prevention of venous thromboembolization following by using elastic bandage
Acronym
The prevention of venous thromboembolization following by using elastic bandage
Scientific Title
The prevention of venous thromboembolization following by using elastic bandage
Scientific Title:Acronym
The prevention of venous thromboembolization following by using elastic bandage
Region
| Japan |
Condition
Condition
Venous thromboembolization
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the prevention effect of venous thromboembolization following total hip arthroplasty y using elastic bandage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of venous thromboambolization at 7days after 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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients undergone total hip arthrplasty in our institution without deep venous thrombosis by ultrasonography before surgery.
Key exclusion criteria
The patients with deep venous thrombosis by ultrasonography before surgery.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | IMAI |
Organization
Niigata University Graduate School
Division name
Div. of Musculoskeletal Medicne
Zip code
9518510
Address
1-757, Asahimachi-dori, Niigata City, Niigata Prefecture, Japan
TEL
0252272272
imainorio2001@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Norio |
| Middle name | |
| Last name | IMAI |
Organization
Niigata University Graduate School
Division name
Div. of Musculoskeletal Medicne
Zip code
9518510
Address
1-757, Asahimachi-dori, Niigata City, Niigata Prefecture, Japa
TEL
0252272272
Homepage URL
imainorio2001@yahoo.co.jp
Sponsor or person
Institute
Niigata University Graduate School
Institute
Department
Personal name
Funding Source
Organization
None
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
Niigata University Graduate School
Address
1-757, Asahimachi-dori, Niigata City, Niigata Prefecture, Japan
Tel
0252272272
imainorio2001@yahoo.co.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
| 2021 | Year | 04 | Month | 12 | Day |
Related information
URL releasing protocol
https://doi.org/10.3390/jcm13154355
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.3390/jcm13154355
Number of participants that the trial has enrolled
150
Results
The surgical time (122.2 min vs. 155.5 min), the incidence of DVT (4.5% vs. 4.8%)
and pulmonary thromboembolism (PTE) (0% vs. 0.7%), intraoperative bleeding (305.4 mL vs. 301
mL), and estimated actual blood loss (846.6 mL vs. 811.6 mL) were not significantly different
between the CaM and EB group. However, there was one case of symptomatic PTE in the EB group.
Results date posted
| 2026 | Year | 04 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 363 patients who underwent unilateral primary THA at our hospital between 1 August 2018 and 31
October 2023, CaM without anticoagulation therapy was administered to 206 patients (CaM group)
and 157 patients underwent EB without anticoagulation therapy (EB group). Duplex
ultrasonography was performed 7 days postoperatively to check for deep vein thrombosis (DVT) in
both legs.
Participant flow
Of the 363 patients who underwent unilateral primary THA at our hospital between 1 August 2018 and 31
October 2023, CaM without anticoagulation therapy was administered to 206 patients (CaM group)
and 157 patients underwent EB without anticoagulation therapy (EB group). Duplex
ultrasonography was performed 7 days postoperatively to check for deep vein thrombosis (DVT) in
both legs.
Adverse events
none
Outcome measures
Of the 363 patients who underwent unilateral primary THA at our hospital between 1 August 2018 and 31
October 2023, CaM without anticoagulation therapy was administered to 206 patients (CaM group)
and 157 patients underwent EB without anticoagulation therapy (EB group). Duplex
ultrasonography was performed 7 days postoperatively to check for deep vein thrombosis (DVT) in
both legs.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 06 | 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
None
Management information
Registered date
| 2021 | Year | 04 | Month | 11 | Day |
Last modified on
| 2026 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050114
