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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013134
Receipt No. R000015252
Scientific Title Prediction of portal vein thrombosis after splenectomy and its primary prophylaxis with antithrombin III concentrates in liver cirrhosis with portal hypertension
Date of disclosure of the study information 2014/02/12
Last modified on 2014/02/11

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Basic information
Public title Prediction of portal vein thrombosis after splenectomy and its primary prophylaxis with antithrombin III concentrates in liver cirrhosis with portal hypertension
Acronym Risk level of PVT after splenectomy and prophylaxis with AT-III
Scientific Title Prediction of portal vein thrombosis after splenectomy and its primary prophylaxis with antithrombin III concentrates in liver cirrhosis with portal hypertension
Scientific Title:Acronym Risk level of PVT after splenectomy and prophylaxis with AT-III
Region
Japan

Condition
Condition Cirrhotic patients who underwent laparoscopic splenectomy
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to classify risk level of portal vein thrombosis after splenectomy in cirrhotic patients and to develop its prophylactic treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To classify risk level of portal vein thrombosis (PVT) after splenectomy in cirrhotic patients
Key secondary outcomes To develop prophylactic treatments of PVT according to the risk level of PVT after splenectomy in cirrhotic patients

Base
Study type

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 intravenous infusion of 1,500 units of AT-III concentrates (Anthrobin P®; CSL Behring, Tokyo, Japan) over approximately 1 hour on postoperative day 1, 2, and 3
Interventions/Control_2 intravenous administration of AT-III concentrates (1500 units/day) for three days followed by intravenous administration of danaparoid Na (2,500 units/day) for 7 ~ 14 days and subsequent administration of warfarin
Interventions/Control_3 No treatment
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 Cirrhotic patients who underwent laparoscopic splenectomy
Key exclusion criteria 1. Patients who had portal vein thrombosis before the operation
2. Patients who had postoperative bleeding requiring hemostasis
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirofumi Kawanaka
Organization Fukuoka City Hospital
Division name Department. of Surgery
Zip code
Address 13-1 Yoshizuka-honmachi, Hakata-ku, Fukuoka-shi, Fukuoka, 812-0046 Japan
TEL 092-632-1111
Email harrykw@v102.vaio.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirofumi Kawanaka
Organization Fukuoka City Hospital
Division name Department of Surgery
Zip code
Address 13-1 Yoshizuka-honmachi, Hakata-ku, Fukuoka-shi, Fukuoka, 812-0046 Japan
TEL 092-632-1111
Homepage URL
Email harrykw@v102.vaio.ne.jp

Sponsor
Institute Department of Surgery, Fukuoka City Hospital
Institute
Department

Funding Source
Organization This work was partly supported by a Grant-in-Aid for Scientific Research (Grant 25893166) from the Japan Society for the Promotion of Science.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Surgery nd Science, Graduate School of Medical Sciences, Kyushu University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 福岡市民病院(福岡市)、九州大学 消化器・総合外科(福岡市)

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 12 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 Completed
Date of protocol fixation
2008 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2013 Year 05 Month 31 Day
Date of closure to data entry
2013 Year 05 Month 31 Day
Date trial data considered complete
2013 Year 12 Month 31 Day
Date analysis concluded
2014 Year 02 Month 11 Day

Other
Other related information

Management information
Registered date
2014 Year 02 Month 11 Day
Last modified on
2014 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015252

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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