UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055771 |
|---|---|
| Receipt number | R000063743 |
| Scientific Title | Review of the incidence of venous thromboembolism and prevention awareness activities following the 2024 Noto Peninsula earthquake |
| Date of disclosure of the study information | 2024/10/08 |
| Last modified on | 2024/10/07 23:58:35 |
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Basic information
Public title
Verification of the number of patients witheconomy class syndrome and prevention activities following the Noto Peninsula earthquake
Acronym
Verification of the number of patients witheconomy class syndrome and prevention activities following the Noto Peninsula earthquake
Scientific Title
Review of the incidence of venous thromboembolism and prevention awareness activities following the 2024 Noto Peninsula earthquake
Scientific Title:Acronym
Review of the incidence of venous thromboembolism and prevention awareness activities following the 2024 Noto Peninsula earthquake
Region
| Japan |
Condition
Condition
venous thromboembolism
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
"Following previous disasters in Japan, an increased incidence of venous thromboembolism (VTE) has been reported among evacuees residing in shelters or sleeping in their vehicles. This highlights the importance of raising awareness about VTE prevention, as well as ensuring early detection and timely treatment.
In response to the Noto Peninsula Earthquake, which occurred on 1 January 2024, the Japanese Society of Phlebology promptly redistributed elastic stockings that had been stockpiled across the country to the affected areas. They collaborated with medical rescue teams to implement VTE prevention awareness initiatives, while also leveraging media platforms to disseminate information about VTE and emphasize the importance of preventive measures. In certain regions, systematic frameworks and manuals were developed to guide these activities, enabling healthcare professionals to carry out coordinated prevention and awareness campaigns. In addition, DVT echo screening was conducted in some areas, providing data for analyzing risk factors associated with VTE.
This study aims to evaluate the effectiveness of VTE prevention and awareness activities, as well as the early detection and treatment efforts, following the Noto Peninsula Earthquake. The findings from this study are expected to contribute to the development of strategies to reduce disaster-related deaths from VTE, particularly in the context of future major disasters, such as the anticipated Nankai Trough earthquake."
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of DVT and pulmonary embolism
Key secondary outcomes
Evacuation patterns of disaster victims after a disaster (evacuation centres, evacuation in cars), whether or not they wore elastic stockings, DVT risk factors, etc.
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
VTE patients who were examined at hospitals in the disaster-affected prefectures (Ishikawa and Toyama)
Key exclusion criteria
Facilities that have not been able to cooperate with data collection
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Teshima |
Organization
Fukuokawajiro Hospital
Division name
Vascular and Endovascular Surgery
Zip code
811-0213
Address
2-2-75 Wajirogaoka Higasiku, Fukuoka, Fukuoka, Japan
TEL
092-608-0001
teshima825@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hosokawa |
Organization
Musashigaoka Hospital (Tanakakai Medical Corp.)
Division name
Department of Rehabilitation Medicine
Zip code
861-8003
Address
7-15-1 Kusunoki, Kita-ku, Kumamoto City, Kumamoto Prefecture, Japan
TEL
0963391161
Homepage URL
hiroshi0614@hotmail.com
Sponsor or person
Institute
others
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
Fukuokawajiro Hospital
Address
2-2-75 Wajirogaoka Higasiku, Fukuoka, Fukuoka, Japan
Tel
092-608-0001
fwh-yakuri@deluxe.ocn.ne.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
| 2024 | Year | 10 | Month | 08 | 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
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 19 | 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
Disaster medical workers acknowledge that VTE prevention and awareness-raising activities have demonstrated a certain degree of effectiveness in the past. Notably, there is a consensus that early-stage prevention and awareness campaigns, conducted in collaboration between healthcare professionals and the media, are particularly beneficial. As a result, in recent disasters, such initiatives have been implemented relatively early, primarily led by medical professionals in partnership with media outlets. However, there remains a scarcity of large-scale studies examining the incidence of VTE in disaster settings.In this study, we aim to gain scientifically valuable insights into cardiovascular disease management during future disasters by conducting a survey on the actual number of VTE cases in the disaster-affected area before and after the event, as well as examining the effectiveness of prevention and treatment interventions. This retrospective observational study is designed based on the number of cases that can be realistically investigated within the study period, informed by the actual number of cases treated in the disaster region
Management information
Registered date
| 2024 | Year | 10 | Month | 08 | Day |
Last modified on
| 2024 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063743
