UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012422 |
|---|---|
| Receipt number | 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 09:01:38 |
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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
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
kaibori@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014542
