UMIN-CTR Clinical Trial
| Recruitment status | Main results already published |
| Unique ID issued by UMIN | UMIN000038278 |
| Receipt No. | R000043632 |
| Scientific Title | Vein echogenic findings of lower limbs and hemostatic function test with field of tsunami stricken area |
| Date of disclosure of the study information | 2019/10/11 |
| Last modified on | 2019/10/11 (Ver. 1) |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
| Basic information | ||
| Public title | Vein echogenic findings of lower limbs and hemostatic function test with field of tsunami stricken area | |
| Acronym | Deep vein thrombosis screening in the area affected by the tsunami | |
| Scientific Title | Vein echogenic findings of lower limbs and hemostatic function test with field of tsunami stricken area | |
| Scientific Title:Acronym | Deep vein thrombosis screening in the area affected by the tsunami | |
| Region |
|
|
| Condition | |||||
| Condition | deep vein thrombus | ||||
| Classification by specialty |
|
||||
| Classification by malignancy | Others | ||||
| Genomic information | NO | ||||
| Objectives | |
| Narrative objectives1 | deep vein thrombus in Disaster Area |
| Basic objectives2 | Others |
| Basic objectives -Others | Reduction of disaster-related death |
| Trial characteristics_1 | Others |
| Trial characteristics_2 | Others |
| Developmental phase | Not applicable |
| Assessment | |
| Primary outcomes | Transition of deep vein thrombosis in the area affected by the tsunami from 2 to 5 years after the Great East Japan Earthquake |
| 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 |
|
|||
| Age-upper limit |
|
|||
| Gender | Male and Female | |||
| Key inclusion criteria | Residents of Tsunami Afflicted Area | |||
| Key exclusion criteria | Those who can not obtain consent | |||
| Target sample size | 1000 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
|
||||||
| Organization | Faculty of Medical Science, University of Fukui | ||||||
| Division name | Deparement of Community Medicine | ||||||
| Zip code | 910-1193 | ||||||
| Address | 23-3, Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui | ||||||
| TEL | 0776-61-3111 | ||||||
| kapi@u-fukui.ac.jp | |||||||
| Public contact | |||||||
| Name of contact person |
|
||||||
| Organization | Faculty of Medical Science, University of Fukui | ||||||
| Division name | Deparement of Community Medicine | ||||||
| Zip code | 910-1193 | ||||||
| Address | 23-3, Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui | ||||||
| TEL | 0776-61-3111 | ||||||
| Homepage URL | |||||||
| kapi@u-fukui.ac.jp | |||||||
| Sponsor | |
| Institute | Faculty of Medical Science, University of Fukui |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Japan Society of Promotion of Science |
| 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 | Fukui University School of Medicine Ethics Committee |
| Address | 23-3, Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui |
| Tel | 0776-61-8529 |
| chiken@ml.u-fukui.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 |
|
||||||
| Related information | |
| URL releasing protocol | No URL |
| Publication of results | Partially published |
| Result | |||||||
| URL related to results and publications | No URL | ||||||
| Number of participants that the trial has enrolled | 1130 | ||||||
| Results | The DVT detection rate of subjects during the period increased every year (2-5 years after the disaster) |
||||||
| Results date posted |
|
||||||
| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results | |||||||
| Baseline Characteristics | Victim |
||||||
| Participant flow | Excludes those with incomplete questionnaire |
||||||
| Adverse events | None |
||||||
| Outcome measures | Evaluation for DVT |
||||||
| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Main results already published | ||||||
| Date of protocol fixation |
|
||||||
| Date of IRB |
|
||||||
| Anticipated trial start date |
|
||||||
| Last follow-up date |
|
||||||
| Date of closure to data entry | |||||||
| Date trial data considered complete | |||||||
| Date analysis concluded | |||||||
| Other | |
| Other related information | Descriptive epidemiology research
Case control study Cross-sectional research |
| Management information | |||||||
| Registered date |
|
||||||
| Last modified on |
|
||||||
| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043632 |
