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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014580
Receipt No. R000016960
Scientific Title The study for the relation of FXIII activity with intraoperative bleeding and morbidity in hepatobiliary surgery.
Date of disclosure of the study information 2014/08/01
Last modified on 2015/12/18

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Basic information
Public title The study for the relation of FXIII activity with intraoperative bleeding and morbidity in hepatobiliary surgery.
Acronym The study for the relation of FXIII activity with intraoperative bleeding.
Scientific Title The study for the relation of FXIII activity with intraoperative bleeding and morbidity in hepatobiliary surgery.
Scientific Title:Acronym The study for the relation of FXIII activity with intraoperative bleeding.
Region
Japan

Condition
Condition Patients who are going to undergo hepatic lobectomy or pancreaticoduodenectomy (irrespective of disease type)
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To test the hypothesis as the following;
Perioeprative deterioration of factor XIII activity leads to an increased intraoperative bleeding and incidence of postoperative complications.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The association between the activity of factor XIII and intraoperative bleeding, intra/postoperative blood transfusion.
Key secondary outcomes The association between the activity of factor XIII and postoperative liver failure, bile leakage, pancreatic fistula, anastomotic failure, and infectious complications.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) patients age at 20 or more
2) patients who undergo hepatic lobectomy or pancreaticoduodenectomy (irrespective of disease).
3) patients who agreed to participate this study
Key exclusion criteria 1) patients who refused to participate this study
2) patients who are not eligible to participate this study (by the decision of responsible physician)
Target sample size 80

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Masato Nagino
Organization Nagoya University Graduate School of Medicine
Division name Division of Surgical Oncology, Department of Surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL 052-744-2222
Email nagino@med.nagoya-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yukihiro Yokoyama
Organization Nagoya University Hospital
Division name Surgery 1
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL 052-744-2222
Homepage URL
Email yyoko@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Division of Surgical Oncology, Department of Surgery
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine
Division of Surgical Oncology, Department of Surgery
Organization
Division
Category of Funding Organization Other
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 08 Month 01 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
2014 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 08 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 Before starting the study

Management information
Registered date
2014 Year 07 Month 17 Day
Last modified on
2015 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016960

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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