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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002898
Receipt No. R000003535
Scientific Title Prospective Validation of Transfusion Criteria after Liver Resection: A Step-Escalation Design
Date of disclosure of the study information 2009/12/15
Last modified on 2010/12/16

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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
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
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
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

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
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
2005 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
Registered date File name

Research case data
Registered date File name


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