UMIN-CTR Clinical Trial

Basic information
Public title	Prospective Validation of Transfusion Criteria after Liver Resection: A Step-Escalation Design
Acronym	Prospective Validation of Transfusion after Liver Resection
Scientific Title	Prospective Validation of Transfusion Criteria after Liver Resection: A Step-Escalation Design
Scientific Title:Acronym	Prospective Validation of Transfusion after Liver Resection
Region	Japan

Condition
Condition	the patients who have malignant liver tumor and underwent liver resection in Nihon University School of Medicine
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To reduce the post operative human blood products transfusion, we prospectively clarify the optimal limit for FFP transfusion after liver resection by phase I manner.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	increase of middle grade postoperative complication without human blood products
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
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Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	The incursion criteria of this study were satisfied the following eligibility: histologically confirmed malignancies, age from 20 to 80 years, well-preserved liver function as Child-Pugh classification A, enable to curative hepatic resection and adequate bone-marrow and renal reserve (blood white cell count >3000/L, platelet >50000/L and serum creatinine <1.5mg/dL).
Key exclusion criteria	The exclusion criteria considered preoperative serum albumin is less than 3.0mg/dL, intraoperative blood loss of more than 1000ml and occurrence of unstable cardiovascular, renal conditions or other serious medical illnesses which conditions cannot be rescued without albumin administration.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shintaro Yamazaki
Organization	Nihon University School of Medicine
Division name	Department of Digestive Surgery
Zip code
Address	30-1 Ohyaguchi Kami-mach Itabashi-ku Tokyo Japan
TEL	+81-3-3972-8111
Email

Public contact
Name of contact person	1st name Middle name Last name Shintaro Yamazaki
Organization	Nihon University School of Medicine
Division name	Department of Digestive Surgery
Zip code
Address
TEL
Homepage URL
Email	yamazaki-nmed@umin.ac.jp

Sponsor
Institute	Nihon University School of Medicine partment of Digestive Surgery
Institute
Department

Funding Source
Organization	None
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Category of Funding Organization	Other
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IRB Contact (For public release)
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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	2009 Year 12 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Progress
Recruitment status	Completed
Date of protocol fixation	2005 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date	2007 Year 07 Month 01 Day
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Date trial data considered complete
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Other

Other related information

A dose-escalation design which commonly used in phase I study is applied with some modifications. The starting step of serum albumin value is 3.0g/dl (Step 1), which is to be reducing every 0.2g/dL by step: ex. 2.8mg/dL (Step 2), 2.6mg/dL (Step 3). The step can escalated to the next value when the serum albumin could reach to prescribed value in three patients. If the serum albumin value of post operative day (POD) 2 fell below the prescribed value, 100ml of 25% albumin was transfused on POD2 and 3 to each patient. The step was proceeded until the post operative complication (POC) without transfusion was occurred or the serum albumin considered reaching the lowest limit.

Management information
Registered date	2009 Year 12 Month 15 Day
Last modified on	2010 Year 12 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003535

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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