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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000019922
Receipt No. 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 2018/06/25

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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
Last name of lead principal investigator
1st name
Middle name
Last name Maruyama Yuki
Organization Shinshu University school of medicine
Division name Anesthesiology and resuscitology
Zip code
Address Asahi 3-1-1, Matsumoto, Nagano
TEL 0263-37-2670
Email yukio.afternoon.tea@gmail.com

Public contact
1st name of contact person
1st name
Middle name
Last name Maruyama Yuki
Organization Shinshu University school of medicine
Division name Anesthesiology and resuscitology
Zip code
Address Asahi 3-1-1, Matsumoto, Nagano
TEL 0263-37-2670
Homepage URL
Email yukio.afternoon.tea@gmail.com

Sponsor
Institute The department of anesthesiology and resuscitology Shinshu University school of medicine
Institute
Department

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
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
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
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
Date of protocol fixation
2015 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 25 Day
Last follow-up date
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
2018 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


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