UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017921 |
|---|---|
| Receipt number | 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 20:52:02 |
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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 | Obstetrics 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
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
ykotake@med.toho-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Toho University Ohashi Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020767
