UMIN-CTR Clinical Trial

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
Email	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
Email	tsukoba@hiroshima-u.ac.jp

Sponsor
Institute	Gasroenterological Surgery, Hiroshima University Hospital
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021806