UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000015 |
|---|---|
| Receipt number | R000000029 |
| Scientific Title | Randamized clinical trial for effect of intraoperative auto blood donation for bleeding during liver resection in living liver transplantation |
| Date of disclosure of the study information | 2005/08/23 |
| Last modified on | 2007/02/02 21:37:33 |
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Basic information
Public title
Randamized clinical trial for effect of intraoperative auto blood donation for bleeding during liver resection in living liver transplantation
Acronym
Auto blood donation and intraoperative bleeding in hepatic resection
Scientific Title
Randamized clinical trial for effect of intraoperative auto blood donation for bleeding during liver resection in living liver transplantation
Scientific Title:Acronym
Auto blood donation and intraoperative bleeding in hepatic resection
Region
| Japan |
Condition
Condition
Living liver donor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The relationship between central venous pressure and amount of bleeding during hepatic resection has been proven. In addition, we experienced that intraoperative auto blooed donatine was effective to control intraoperative bleeding when massive bleeding occured during hepatic resection. The aim of this study is to clarify the effect of auto blood donation for intraoperative bleeding in hepatic surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
amount of bleeding during hepatic resection
Key secondary outcomes
total amount of bleeding in operation, time of hepatic resectioon, duration of hospital stay.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Participated patients will be divided into two groups randomaly. One is blood donotion group and the other is non-blood donoation group. Pstients in blood donation group will be donated auto blood which is equal to 0.7 % of their body weight at the begining of the operation. It will be tranptranted to them before the operation will be finished.
Interventions/Control_2
Patients in non-blood donoation group will not be added extra treatment or intervention.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Living liver donor
2) Age>=18 years old
3) Male and female
4) Patients with imformed concsent
Key exclusion criteria
1) Patients with hypertension or hypotension
2) Patients with remarkable abnormal anatomy of the liver
3) patients with anemia (Hb<11g/dl)
4) Patients with comorbidity
5) Patients with tendency of bleeding
6) Patients who would not achieve stable circulation condition during operation
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatoshi Makuuchi |
Organization
University of Tokyo
Division name
Department of Surgery, Hepato-Biliary-Pancreatic Surgery Division, Artificial Organ and Transplantation Division
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan 113-8655
TEL
03-3815-5411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Tokyo
Division name
Department of Surgery, Hepato-Biliary-Pancreatic Surgery Division, Artificial Organ and Transplantat
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan 113-8655
TEL
03-3815-5411
Homepage URL
thashimo-tky@umin.ac.jp
Sponsor or person
Institute
University of Tokyo,Department of Surgery, Hepato-Biliary-Pancreatic Surgery Division, Artificial Organ and Transplantatation
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2005 | Year | 08 | Month | 23 | 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
Intraoperative blood salvage before liver parenchymal resection can significantly reduse the amount of blood loss during liver resection in living donor hepatectomy.
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
Date of protocol fixation
| 2003 | Year | 10 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2006 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2006 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2006 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 06 | Month | 22 | Day |
Last modified on
| 2007 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000029
