A clinical trial to comparison the effectiveness of common ultrasound-guided with the recently invented device in treatment of the angiography-induced pseudoaneurysm
The effectiveness of common ultrasound-guided with the recently invented device in treatment of the angiography-induced pseudoaneurysm
Design
In this pragmatic double-blind, controlled clinical trial, 22 patients with pseudoaneurysm caused by angiography were assigned into parallel groups using the table of random numbers in a community-based setting.
Settings and conduct
Patients with pseudoaneurysm caused by angiography in Ghaem Hospital, Mashhad, Iran, were chosen. In this double-blind study, the clinical care and data collector were blind to group assignment and the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with pseudoaneurysm caused by angiography base on color Doppler ultrasound diagnostic criteria.
Exclusion criteria: Complete aneurysm block; complete thrombosis of the pseudoaneurysm; abscess, surface tissue infection, or open wound in the area; history of angiography.
Intervention groups
The control group will ultrasound-guided compression by hand. The intervention group will receive ultrasound-guided compression by the invented device.
Main outcome variables
Evaluation and comparison of length, width and neck of pseudoaneurysm and pain levels before and 6 hours after the intervention in the intervention and control groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190701044059N1
Registration date:2019-07-14, 1398/04/23
Registration timing:prospective
Last update:2019-07-14, 1398/04/23
Update count:0
Registration date
2019-07-14, 1398/04/23
Registrant information
Name
Zahra Kermani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3606 5215
Email address
kermaniz@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to comparison the effectiveness of common ultrasound-guided with the recently invented device in treatment of the angiography-induced pseudoaneurysm
Public title
Effect of recently invented device in treatment of the angiography-induced pseudoaneurysm
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with pseudoaneurysm caused by angiography base on color Doppler ultrasound diagnostic criteria
Exclusion criteria:
Complete aneurysm block
Complete thrombosis of the pseudoaneurysm
Abscess, surface tissue infection, or open wound in the area
History of angiography
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Totally 22 patients with pseudoaneurysm caused by angiography in Ghaem Hospital, Mashhad, Iran, were chosen. The participants were allocated into groups of intervention and control using the table of random numbers based on computer programs.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients with pseudoaneurysm caused by angiography in Ghaem Hospital, Mashhad, Iran, were chosen. In this double-blind study, the clinical care and data collector were blind to group assignment and the type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2019-01-14, 1397/10/24
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.587
Health conditions studied
1
Description of health condition studied
The angiography-induced pseudoaneurysm
ICD-10 code
I72.4
ICD-10 code description
Aneurysm and dissection of artery of lower extremity
Primary outcomes
1
Description
Length, width and neck of pseudoaneurysm
Timepoint
Before and 6 hours after the intervention
Method of measurement
Ultrasound
Secondary outcomes
1
Description
Pain levels
Timepoint
Before and 6 hours after the intervention
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: The intervention group will receive ultrasound-guided compression by the invented device.
Category
Treatment - Devices
2
Description
Control group: The control group will ultrasound-guided compression by hand.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Zahra Kermani
Street address
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
Z-k-65@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Kermani
Position
Residents
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
Z-k-65@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Kermani
Position
Residents
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
Z-k-65@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Kermani
Position
Residents
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
Z-k-65@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The total data to be included are the primary and secondary effects to be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working in science center and university.
Under which criteria data/document could be used
Our data will be available for scholars working in science center and university.
From where data/document is obtainable
Zahra Kermani provides the analysis code to the applicants via email: Z-k-65@yahoo.com
What processes are involved for a request to access data/document
Applicants can respond to the email of the respondent and receive a response within a week.