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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000031932
Receipt No. R000036471
Scientific Title Clinical study on the mechanism of blood reflux prevention of Surplug CL
Date of disclosure of the study information 2018/03/27
Last modified on 2018/12/03

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Basic information
Public title Clinical study on the mechanism of blood reflux prevention of Surplug CL
Acronym Clinical study on the mechanism of blood reflux prevention of Surplug CL
Scientific Title Clinical study on the mechanism of blood reflux prevention of Surplug CL
Scientific Title:Acronym Clinical study on the mechanism of blood reflux prevention of Surplug CL
Region
Japan

Condition
Condition Patients with peripheral IV catheters
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparing effectiveness of heparin lock with use of Suplug CL and the currently existing practice.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ratio of potency 4 days after the heparin flush
Frequency of adverse events
Nurse questionnaire survey
Key secondary outcomes Lengths of catheterization
Reasons for interruption
Existence of thrombosis
(macroscopic observation)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 3-way-stopcock Group
Extension tube with 3-way-stopcock Group
n=20
Interventions/Control_2 Surplug CL Group
Surplug CL Extension tube Group
n=20
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with peripheral IV catheter
Key exclusion criteria Patients who are planned to receive anticoagulant or thrombolysis.
Patients who have a history of hypersensitivity reactions to heparin.
Patients who are pregnant,breast-feeding or potentially pregnant.
Other patients assessed "not applicable" by doctors.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Mizuno
Organization Mejiro Second General Hospital
Division name Department of Surgery
Zip code
Address 1980 Fussa,Fussa,Tokyo,197-0011,Japan
TEL 042-553-3511
Email zbm05143@sky.zero.ad.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Mizuno
Organization Mejiro Second General Hospital
Division name Department of Surgery
Zip code
Address 1980 Fussa,Fussa,Tokyo,197-0011,Japan
TEL 042-553-3511
Homepage URL
Email zbm05143@sky.zero.ad.jp

Sponsor
Institute Mejiro Second General Hospital
Department of Surgery
Institute
Department

Funding Source
Organization Term CO.,LTD.
Organization
Division
Category of Funding Organization Profit organization
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
2018 Year 03 Month 27 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 Terminated
Date of protocol fixation
2018 Year 01 Month 09 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 27 Day
Last modified on
2018 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036471

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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