UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031932 |
|---|---|
| Receipt number | 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 08:09:19 |
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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
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
zbm05143@sky.zero.ad.jp
Sponsor or person
Institute
Mejiro Second General Hospital
Department of Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036471
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
