UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019922 |
|---|---|
| Receipt number | R000023000 |
| Scientific Title | Examination about the intravenous thrombosis caused by femoral venous catheters during neurosurgical anesthesia management. |
| Date of disclosure of the study information | 2015/11/25 |
| Last modified on | 2019/12/14 17:24:05 |
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Basic information
Public title
Examination about the intravenous thrombosis caused by femoral venous catheters during neurosurgical anesthesia management.
Acronym
Examination about the intravenous thrombosis caused by femoral venous catheters.
Scientific Title
Examination about the intravenous thrombosis caused by femoral venous catheters during neurosurgical anesthesia management.
Scientific Title:Acronym
Examination about the intravenous thrombosis caused by femoral venous catheters.
Region
| Japan |
Condition
Condition
brain tumor
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Research of frequency with thrombosis caused by femoral venous catheters during neurosurgical anesthesia management.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency with thrombosis caused by femoral venous catheters during neurosurgical anesthesia management.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled brain tumor removed.
Key exclusion criteria
Hemostatic coagulation system abnormality cases,preoperative vein thrombosis confirmed cases,vein running abnormal cases.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Maruyama |
Organization
Shinshu University school of medicine
Division name
Anesthesiology and resuscitology
Zip code
390-8621
Address
Asahi 3-1-1, Matsumoto, Nagano
TEL
0263-37-2670
yukio.afternoon.tea@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Maruyama |
Organization
Shinshu University school of medicine
Division name
Anesthesiology and resuscitology
Zip code
390-8621
Address
Asahi 3-1-1, Matsumoto, Nagano
TEL
0263-37-2670
Homepage URL
yukio.afternoon.tea@gmail.com
Sponsor or person
Institute
The department of anesthesiology and resuscitology Shinshu University school of medicine
Institute
Department
Personal name
Funding Source
Organization
The department of anesthesiology and resuscitology Shinshu University school of medicine
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
The department of anesthesiology and resuscitology Shinshu University school of medicine
Address
Asahi 3-1-1, Matsumoto, Nagano
Tel
0263-37-2670
yukio.afternoon.tea@gmail.com
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
| 2015 | Year | 11 | Month | 25 | 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
200
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Case-control study.
In patients undergoing craniotomy for brain tumor in our facilities from November 25, 2015 until October 31, 2020, all that meet the selection criteria.
Age, height, weight, complications, platelet count, PT-INR, APTT, D-dimer, fibrinogen, surgery time, anesthesia time, intraoperative transfusion volume, urine volume, I measure and amount of bleeding .
Management information
Registered date
| 2015 | Year | 11 | Month | 25 | Day |
Last modified on
| 2019 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023000
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
