UMIN-CTR Clinical Trial

Basic information
Public title	Transfusion criteria for fresh frozen plasma in liver resection.
Acronym	Criteria for FFP in liver resection.
Scientific Title	Transfusion criteria for fresh frozen plasma in liver resection.
Scientific Title:Acronym	Criteria for FFP in liver resection.
Region	Japan

Condition
Condition	The patients who recieve liver resection.
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To establish transfusion criteria for use of fresh frozen plasma in liver resection.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	increase of middle grade postoperative complication without FFP.
Key secondary outcomes

Base
Study type

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A dose-escalation design which commonly used in phase I study is applied with some modifications. The starting step of PT-INR value is 1.5 (Step 1), which is added every 0.1 by step: ex. 1.6 (Step 2), 1.7 (Step 3).The step was proceeded until the post operative complication (POC) without transfusion was occurred or PT-INR is 3.0.
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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	The patinets who undergo liver resection.
Key exclusion criteria	Otherserious medical illnesses which conditions cannot be rescued without FFP.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Takafumi Middle name Last name Kumamoto
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan
TEL	045-787-2650
Email	t.kumamoto@k5.dion.ne.jp

Public contact
Name of contact person	1st name Takafumi Middle name Last name Kumamoto
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Zip code	2360004
Address	3-9 Fukuura, Kanazawa-Ku, Yokohama 236-0004 Japan
TEL	045-787-2650
Homepage URL
Email	t.kumamoto@k5.dion.ne.jp

Sponsor
Institute	Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine
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	Yokohama City University Graduate School of Medicine
Address	3-9 Fukuura, Kanazawa-Ku, Yokohama 236-0004 Japan
Tel	0457872650
Email	t.kumamoto@k5.dion.ne.jp

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	2013 Year 04 Month 08 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	Terminated
Date of protocol fixation	2013 Year 03 Month 31 Day
Date of IRB	2013 Year 03 Month 31 Day
Anticipated trial start date	2013 Year 04 Month 08 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 03 Month 31 Day
Last modified on	2020 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012139