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

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 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


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

Value
https://center6.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