UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002898 |
|---|---|
| Receipt number | 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 18:05:02 |
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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
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
yamazaki-nmed@umin.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine partment of Digestive Surgery
Institute
Department
Personal name
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
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
Value
https://center6.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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| Registered date | File name |
| Research case data | |
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