UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013134 |
|---|---|
| Receipt number | 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 16:33:58 |
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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
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
harrykw@v102.vaio.ne.jp
Sponsor or person
Institute
Department of Surgery, Fukuoka City Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015252
