UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018852 |
|---|---|
| Receipt number | R000021806 |
| Scientific Title | Efficacy and safety of Antithrombin III administration for the patients with blood coagulation disorder after hepatectomy. |
| Date of disclosure of the study information | 2015/09/20 |
| Last modified on | 2020/02/09 16:47:48 |
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Basic information
Public title
Efficacy and safety of Antithrombin III administration for the patients with blood coagulation disorder after hepatectomy.
Acronym
Efficacy and safety of Antithrombin III administration for the patients with blood coagulation disorder after hepatectomy.
Scientific Title
Efficacy and safety of Antithrombin III administration for the patients with blood coagulation disorder after hepatectomy.
Scientific Title:Acronym
Efficacy and safety of Antithrombin III administration for the patients with blood coagulation disorder after hepatectomy.
Region
| Japan |
Condition
Condition
Blood coagulation disorder after hepatectomy
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Compare the efficacy and safety of Antithrombin III administration for the patients with blood coagulation disorder after hepatectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy (Posthepatectomy Liver Failure)
Key secondary outcomes
Safety, Morbidity rate, Mortality rate, Liver function test, Blood coagulation ability
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A: Administration of gabexate mesilate 1,500mg per day for 4 days after surgery.
Interventions/Control_2
B: Administration of gabexate mesilate 1,500mg per day for 4 days after surgery, and of antithrombin III 1,500mg for 2 days after surgery.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Hepatectomy for hepatic disease
2. Japanese Association for Acute Medicine-defined DIC criteria score > 4 on the day 1st after hepatectomy
3. Written informed consent
4. > = 20 years of age
Key exclusion criteria
1. Clinically significant allergy
2. Clinically significant postoperative liver failure (T.Bil >=5.0mg/dL)
3. Clinically significant postoperative complication
4. Significant lack of antithrombin III (<30%)
5. Splenectomy
6. Presence of anastomosis of alimentary or biliary truct
7. Presence of biliary drainage
8. Clinically significant coagulopathy, renal disfunction or infection
9. Presence of psychological disorder
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ohdan Hideki |
Organization
Hiroshima University Hospital
Division name
Gasroenterological Surgery
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, JAPAN
TEL
082-257-5222
jimukyoku@hisco-jpn.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kobayashi Tsuyoshi |
Organization
Hiroshima University Hospital
Division name
Gasroenterological Surgery
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, JAPAN
TEL
082-257-5222
Homepage URL
http://www.hisco-jpn.com/index.html
tsukoba@hiroshima-u.ac.jp
Sponsor or person
Institute
Gasroenterological Surgery, Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
安佐市民病院（広島県）、尾道総合病院（広島県）、広島総合病院（広島県）、県立広島病院（広島県）、広島大学病院（広島県）、中国労災病院（広島県）、東広島医療センター（広島県）、広島鉄道病院（広島県）、呉医療センター・中国がんセンター（広島県）、吉島病院（広島県）、呉市医師会病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 30 | Day |
Last modified on
| 2020 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021806
