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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040049
Receipt No. 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

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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
Email 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
Email ueshima.daisuke@kameda.jp

Sponsor
Institute Kameda Medical Center
Institute
Department

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
Email 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
URL(English) https://upload.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


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