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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014416
Receipt No. R000016771
Scientific Title The study for the effect of FXIII substitution on intra- and postoperative bleeding in hepatobiliary surgery.
Date of disclosure of the study information 2014/08/01
Last modified on 2014/06/29

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Basic information
Public title The study for the effect of FXIII substitution on intra- and postoperative bleeding in hepatobiliary surgery.
Acronym FXIII and intra- and postoperative bleeding
Scientific Title The study for the effect of FXIII substitution on intra- and postoperative bleeding in hepatobiliary surgery.
Scientific Title:Acronym FXIII and intra- and postoperative bleeding
Region
Japan

Condition
Condition Patients who are going to undergo hepatectomy and pancreaticoduodenectomy
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To test the following hypothesis;
Preoperative FXIII supplementation my reduce intra- and postoperative bleeding in hepatobiliary pancreatic surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Perioperative FXIII activity.
The extent of intra- and postoperative bleeding and blood transfusion.
Key secondary outcomes The amount of postoperative drain volume and hemoglobin concentration.
The incidence rate of postoperative liver failure, bile leakage, pancreatic fistula, anastomotic failure, and infectious complications.

Base
Study type

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 supplementation of FXIII
Interventions/Control_2 non-supplementation of FXIII
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 The patients who are going to undergo hepatectomy or pancreaticoduodenectomy.
The patients who agreed to participate this study.
Key exclusion criteria The patients who refuse to participate this study.
The patients who are not eligible to participate this study that is defined by responsible physicians.
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 +81-527442222
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 +81-527442222
Homepage URL
Email yyoko@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization not applicable
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
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 Preinitiation
Date of protocol fixation
2014 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 15 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
2014 Year 06 Month 29 Day
Last modified on
2014 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016771

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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