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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002289
Receipt No. R000002733
Scientific Title Impact of antithrombin III concentrates on portal vein thrombosis after splenectomy in patients with liver cirrhosis and hypersplenism
Date of disclosure of the study information 2009/08/03
Last modified on 2009/08/03

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Basic information
Public title Impact of antithrombin III concentrates on portal vein thrombosis after splenectomy in patients with liver cirrhosis and hypersplenism
Acronym Impact of AT-III concentrates on PVT after splenectomy in liver cirrhosis
Scientific Title Impact of antithrombin III concentrates on portal vein thrombosis after splenectomy in patients with liver cirrhosis and hypersplenism
Scientific Title:Acronym Impact of AT-III concentrates on PVT after splenectomy in liver cirrhosis
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 is to determine the impact of AT-III concentrates on the development of portal vein thrombosis after laparoscopic splenectomy in cirrhotic patients with hypersplenism.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of the incidence of portal vein thrombosis between cirrhotic patients with or without AT-III concentrates
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Cirrhotic patients who underwent laparoscopic splenectomy received an intravenous infusion of 1,500 units of AT-III concentrates over approximately 1 hour on post-operative day 1, 2, and 3.
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

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 post-operative bleeding requiring hemostasis.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirofumi Kawanaka
Organization Kyushu University Hospital
Division name Department of Surgery and Science
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5466
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hirofumi Kawanaka
Organization Kyushu University Hospital
Division name Department of Surgery and Science
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5466
Homepage URL
Email harrykawa2002@yahoo.co.jp

Sponsor
Institute Department of Surgery and Science, Kyushu University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2009 Year 08 Month 03 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
2005 Year 12 Month 31 Day
Date of IRB
Anticipated trial start date
2006 Year 01 Month 01 Day
Last follow-up date
2006 Year 12 Month 01 Day
Date of closure to data entry
2008 Year 12 Month 01 Day
Date trial data considered complete
2008 Year 12 Month 01 Day
Date analysis concluded
2008 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 08 Month 03 Day
Last modified on
2009 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002733

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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