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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044249
Receipt No. 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 2021/05/18

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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
Email 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
Email leaf0710@nms.ac.jp

Sponsor
Institute Department of Gastroenterology, Nippon Medecial School
Institute
Department

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
Email 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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 64
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 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
2022 Year 07 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
2021 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050534

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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