UMIN-CTR Clinical Trial

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
Email	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
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	The department of anesthesiology and resuscitology Shinshu University school of medicine
Address	Asahi 3-1-1, Matsumoto, Nagano
Tel	0263-37-2670
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023000