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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017921
Receipt No. R000020767
Scientific Title Perioperative change of fluid distribution and coagulation during high risk surgical patients.
Date of disclosure of the study information 2015/07/01
Last modified on 2015/09/14

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Basic information
Public title Perioperative change of fluid distribution and coagulation during high risk surgical patients.
Acronym Perioperative colloid osmotic pressure and coagulation profile.
Scientific Title Perioperative change of fluid distribution and coagulation during high risk surgical patients.
Scientific Title:Acronym Perioperative colloid osmotic pressure and coagulation profile.
Region
Japan

Condition
Condition Elective patients who undergo curative surgery for gastrointestinal, gynecologic and urologic malignancies.
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Obsterics and gynecology
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of intraoperative fluid on colloid osmotic pressure and coagulation profile.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes colloid osmotic pressure
viscoelastic analysis and standard coagulation test
Key secondary outcomes

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
40 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients undergoing elective, curative surgery for gastrointestinal, gynecologic and urologic malignancies.
Key exclusion criteria Known coagulation disorders before surgery
Patients who received either anticoagulation or antiplatelet medication.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshifumi Kotake
Organization Toho University Ohashi Medical Center
Division name Department of Anesthesiology
Zip code
Address 2-17-6, Ohashi, Meguro, Tokyo
TEL 03-3468-1251
Email ykotake@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshifumi Kotake
Organization Toho University Ohashi Medical Center
Division name Department of Anesthesiology
Zip code
Address 2-17-6, Ohashi, Meguro, Tokyo
TEL 03-3468-1251
Homepage URL
Email ykotake@med.toho-u.ac.jp

Sponsor
Institute Department of Anesthesiology, Toho University Ohashi Medical Center
Institute
Department

Funding Source
Organization None
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 東邦大学医療センター大橋病院(東京)
Toho University Ohashi Medical Center (Tokyo)

Other administrative information
Date of disclosure of the study information
2015 Year 07 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 Enrolling by invitation
Date of protocol fixation
2015 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2015 Year 07 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 The correlation between the amount of colloid solution to colloid osmotic pressure and coagulation profile measured with viscoelastic analysis are investigated since colloid solution may increase osmotic pressure while negatively affect coagulation function.

Management information
Registered date
2015 Year 06 Month 16 Day
Last modified on
2015 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020767

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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