UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005451 |
|---|---|
| Receipt number | R000006464 |
| Scientific Title | Randomized controlled trial of PICC catheters |
| Date of disclosure of the study information | 2011/04/16 |
| Last modified on | 2011/06/05 23:18:46 |
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Basic information
Public title
Randomized controlled trial of PICC catheters
Acronym
Randomized controlled trial comparing the tip shape and the material of PICC catheters
Scientific Title
Randomized controlled trial of PICC catheters
Scientific Title:Acronym
Randomized controlled trial comparing the tip shape and the material of PICC catheters
Region
| Japan |
Condition
Condition
chemotherapy of esophageal cancer and/or perioperative intravenous nutritional support
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verification of efficacy and safety
comparing two major peripherally inserted central venous catheters with different material and tip design:a silicone catheter with distal side slits and a polyurethane catheter with open-end tip
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion rate of peripherally inserted central venous catheters placement
Key secondary outcomes
Complications rate(bloodstream infection, hemorrhage at the insertion site, phlebitis, vein thrombosis, and catheter malfunction such as partial/complete occlusion and fracture)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Period: Catheter dwelling time
Used catheter: a silicone catheter with distal side slits (Groshong, Bard Access Systems)
Interventions/Control_2
Period: Catheter dwelling time
Used catheter: a polyurethane catheter with open-end tip (PI Catheter, Covidien)
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
1. Peripherally inserted central venous catheters is needed clinically in chemotherapy or intravenous-nutrition purpose newly
2. A written informed consent was obtained
Key exclusion criteria
1. Taking warfarin or an antiplatelet medicine within two weeks of an insertion day.
2. Past history of pulmonary embolism, deep vein thrombosis, and an endocarditis.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyokazu Nakajima, M.D., Ph.D., F.A.C.S |
Organization
Osaka University, Graduated School of Medicine
Division name
Dept. of Gastroenterological Surgery
Zip code
Address
Yamadaoka 2-2 Suita-shi, Osaka pref, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University, Graduated School of Medicine
Division name
Dept. of Gastroenterological Surgery
Zip code
Address
hmiyagaki@gesurg.med.osaka.ac.jp
TEL
Homepage URL
Sponsor or person
Institute
Osaka University, Graduated School of Medicine, Dept. of Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
Japan Sherwood 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
大阪大学病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 16 | 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
Completed
Date of protocol fixation
| 2010 | Year | 07 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 15 | Day |
Last modified on
| 2011 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006464
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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