UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040049 |
|---|---|
| Receipt number | R000045643 |
| Scientific Title | US-guided puncture and decompression for the management of common femoral artery iatrogenic pseudoaneurysm: A randomized controlled trial |
| Date of disclosure of the study information | 2020/04/10 |
| Last modified on | 2020/07/09 09:05:02 |
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Basic information
Public title
US-guided puncture and decompression for the management of common femoral artery iatrogenic pseudoaneurysm
Acronym
UP-D trial
Scientific Title
US-guided puncture and decompression for the management of common femoral artery iatrogenic pseudoaneurysm: A randomized controlled trial
Scientific Title:Acronym
UP-D trial
Region
| Japan |
Condition
Condition
common femoral artery iatrogenic pseudoaneurysm
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of ultrasound-guided puncture and decompression method for the common femoral artery iatrogenic pseudoaneurysm management
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Success rate of the common femoral artery iatrogenic pseudoaneurysm management after 20-30 procedure
Key secondary outcomes
Any adverse event rate due to the procedure of the common femoral artery iatrogenic pseudoaneurysm management
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Common femoral artery iatrogenic pseudoaneurys management with Ultrasound-guided puncture and decompression method: 1) Puncture the pseudoaneurysm with 18-20G indwelling needle with ultrasound-guiding and place the outer of the needle, 2)Aspirate the pseudoaneurysm with 5-10cc syringe with giving a manual compression to the proximal and distal portion of the pseudoaneurysm, 3)Detach the syringe when the aspiration is stopped, with retrieving the outer of the needle after 1-2 minutes compression, 4)keep the manual compression for 20-30 min
Interventions/Control_2
Common femoral artery iatrogenic pseudoaneurys management with ultrasound guided compression: ultrasound is used to identify the chamber and tract of the pseudoaneurysm. The physician places the ultrasound transducer on the pseudoaneurysm tract and compresses it to block blood flow, and keeps the compression for 20-30 minutes.
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
consecutive cases with common femoral artery iatrogenic pseudoaneurysm
Key exclusion criteria
1. <20-year-old
2. underwent a surgical intervention to the common femoral artery with pseudoaneurysm
3. pseudoaneurysm rupture
4. shock vital
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Ueshima |
Organization
Kameda Medical Center
Division name
Cardiology
Zip code
296-8602
Address
929 Higashi-cho Kamogawa City
TEL
+81-4-7092-2211
ueshima.daisuke@kameda.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ueshima |
Organization
Kameda Medical Center
Division name
Cardiology
Zip code
296-8602
Address
929 Higashi-cho Kamogawa City
TEL
+81-4-7092-2211
Homepage URL
ueshima.daisuke@kameda.jp
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kameda Medical Center
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
Kameda Medical Center Institutional Review Board
Address
929 Higashi-cho Kamogawa City
Tel
+81-4-7092-2211
clinical_research@kameda.jp
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
| 2020 | Year | 04 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 03 | Day |
Last modified on
| 2020 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045643
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/12/18 | UP-D trial研究計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
