UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study for the clinical usefulness of preoperative blood donation before hepatectomy in major hepatectomy. A randomized controlled study.
Title of the study (Brief title)	The study for the clinical usefulness of preoperative blood donation before hepatectomy in major hepatectomy. A randomized controlled study.
Region	Japan

Condition
Condition	Hepato-biliary-pancreatic tumors
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to compare surgical outcomes between patients receiving autologous and homologous transfusions during hepatectomy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative liver failrue, Overall survival
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	blood donation, twice, 400ml*2
Interventions/Control_2	Without blood donation
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	the patient agreed to the storage and was able to attend the hospital as an outpatient the patients Hb level was greater than 11 g dl before storage and the patient was free from severe cardiopulmonary and or cerebrovascular diseases or infection
Key exclusion criteria	Patient who does not fulfill the inclusion criteria.
Target sample size	100

Research contact person
Name of lead principal investigator	Masato Nagino
Organization	Department of Surgery, Nagoya University Graduate School of Medicine
Division name	Division of Surgical Oncology
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL	052-744-2222
Email	nagino@med.nagoya-u.ac.jp

Public contact
Name of contact person	Shunsuke Onoe
Organization	Department of Surgery, Nagoya University Graduate School of Medicine
Division name	Division of Surgical Oncology
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL	052-744-2222
Homepage URL
Email	sonoe@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Surgery, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Surgery, Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2025 Year 03 Month 31 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 06 Month 05 Day
Anticipated trial start date	2018 Year 08 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 06 Month 05 Day
Last modified on	2018 Year 06 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037495