UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044249 |
|---|---|
| Receipt number | R000050534 |
| Scientific Title | Multicenter retrospective study of thrombolytic therapy including AT-III for portal vein thrombosis |
| Date of disclosure of the study information | 2021/05/18 |
| Last modified on | 2024/01/09 13:58:00 |
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Basic information
Public title
Multicenter retrospective study of thrombolytic therapy including AT-III for portal vein thrombosis
Acronym
Efficacy and safety of AT-III for portal vein thrombus
Scientific Title
Multicenter retrospective study of thrombolytic therapy including AT-III for portal vein thrombosis
Scientific Title:Acronym
Efficacy and safety of AT-III for portal vein thrombus
Region
| Japan |
Condition
Condition
portal vein thrombus
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the efficacy and safety of AT-III preparations for portal vein thrombus in clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate and elimination rate of thrombolysis
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who received thrombolytic therapy for portal vein thrombosis
2. Age: 18 years old and over
3. Gender: It doesn't matter
Key exclusion criteria
none
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Atsukawa |
Organization
Nippon Medecial School
Division name
Department of Gastroenterology
Zip code
113-8602
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
0338222131
momogachi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Korenobu |
| Middle name | |
| Last name | Hayama |
Organization
Noppn Medical School Chibahokusoh Hospital
Division name
division of gastroenterology
Zip code
2701694
Address
1715 Kamagari, Inzai City, Chiba Prefecture
TEL
0476991111
Homepage URL
leaf0710@nms.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Nippon Medecial School
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Chiba Hokuso Hospital Ethics Committee
Address
1715 Kamagari, Inzai City, Chiba Prefecture
Tel
0476991111
hokusoh.ethics.group@nms.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
| 2021 | Year | 05 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
240
Results
This study suggests that maintenance therapy, favorable response, and absence of PVT progression may suppress or control liver-related events in antithrombin III-based therapy for patients with PVT. Specifically, maintenance therapy could suppress not only liver-related events, but also PVT progression and improve the prognosis.
Results date posted
| 2024 | Year | 01 | Month | 09 | Day |
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective study will be conducted on patients who have undergone thrombolytic therapy including AT-III for portal vein thrombosis since August 2017 at a registered facility.
Management information
Registered date
| 2021 | Year | 05 | Month | 18 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050534
