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UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000015
Receipt No. 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

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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
Email

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
Email thashimo-tky@umin.ac.jp

Sponsor
Institute University of Tokyo,Department of Surgery, Hepato-Biliary-Pancreatic Surgery Division, Artificial Organ and Transplantatation
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000029

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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