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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012422
Receipt No. R000014542
Scientific Title Examination of the perioperative period hemoglobin and a renal function by patient of hepatocellular carcinoma who undergoes intraoperative blood salvage for a extraction operation.
Date of disclosure of the study information 2014/01/06
Last modified on 2014/01/24

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Basic information
Public title Examination of the perioperative period hemoglobin and a renal function by patient of hepatocellular carcinoma who undergoes intraoperative blood salvage for a extraction operation.
Acronym Examination of the perioperative period hemoglobin and a renal function by patient of hepatocellular carcinoma who undergoes intraoperative blood salvage for a extraction operation.
Scientific Title Examination of the perioperative period hemoglobin and a renal function by patient of hepatocellular carcinoma who undergoes intraoperative blood salvage for a extraction operation.
Scientific Title:Acronym Examination of the perioperative period hemoglobin and a renal function by patient of hepatocellular carcinoma who undergoes intraoperative blood salvage for a extraction operation.
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Nephrology Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examination of the maintenance of perioperative period hemoglobin and volume of blood salvage by renal function by patient of hepatocellular carcinoma who undergoes intraoperative blood salvage for a extraction operation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.Volume of blood salvage by renal function.
2.Maintenance of perioperative period hemoglobin
Key secondary outcomes

Base
Study type Interventional

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 Epoetin Beta 24000IU
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patient of hepatocellular carcinoma who undergoes intraoperative blood salvage for a extraction operation.
2. Patients acquired informed consent about this study and fill in consent document after they gives sufficient explanation.
Key exclusion criteria 1. Patients with known hypersensitivity to Erythropoiesis-stimulating agents (Epoetin alfa,Epoetin beta, Darbepoetin alfa,Epoetin beta pegol)
2. Patients under 20 years old.
3. Patients judged inappropriate by attending physicians.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki kaibori
Organization Kansai Medical University
Division name Surgery
Zip code
Address 2-5-1 sinmachi Hirakata city Osaka
TEL 072-804-0101
Email kaibori@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaki kaibori
Organization Kansai Medical University
Division name Surgery
Zip code
Address 2-5-1 sinmachi Hirakata city Osaka
TEL 072-804-0101
Homepage URL
Email kaibori@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization None
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
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
2014 Year 01 Month 06 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 Open public recruiting
Date of protocol fixation
2013 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
2014 Year 02 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

Management information
Registered date
2013 Year 11 Month 27 Day
Last modified on
2014 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014542

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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