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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name