Comparison of the efficacy and safety of autologous blood injection with c-clamp vascular closure device in treatment of iatrogenic pseudoaneurysm after femoral artery puncture
Comparison of the efficacy and safety of autologous blood injection with c-clamp vascular closure device in treatment of iatrogenic pseudoaneurysm after femoral artery puncture
Design
Clinical trial with control group with parallel groups, phase 2 on 105 patients
Settings and conduct
This study is performed in Chamran Hospital in Isfahan. Patients will be cared for in two ways. The success rate of the treatment method in closing pseudoaneurysm and the complications of treatment in both groups of patients will be evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with pseudoaneurysm of femoral artery following angiography, pseudoaneurysm size greater than 2 cm, patients' consent to enter the study.
Exclusion criteria: Active infection of groin area, hematoma larger than 2 cm on ultrasound, skin necrosis, symptoms of lower limb ischemia
Intervention groups
Intervention group 1: Patients in this group, after diagnosis of femoral artery pseudoaneurysm, under mechanical compression by C-clamp, the pressure of which is marked under the ultrasound guide, and then the amount of pressure applied to the site of the sheath is applied. That homeostasis is established while the distal pulse of the lower limb is palpable. The rate of improvement and treatment complications in patients are evaluated.
Intervention group 2: Patients in this group, after diagnosis of pseudoaneurysm of the femoral artery, 10 to 20 cc of the patient's blood is injected by the same sonographer according to the sonographer's estimate of the sac volume after clot formation under the ultrasound guide in sterile conditions in the pseudoaneurysm sac. The rate of improvement and treatment complications in patients are evaluated.
Main outcome variables
Success rate of treatment in closing pseudoaneurysm and treatment complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210614051574N7
Registration date:2022-01-07, 1400/10/17
Registration timing:prospective
Last update:2022-01-07, 1400/10/17
Update count:0
Registration date
2022-01-07, 1400/10/17
Registrant information
Name
Ghasem Mohammadsharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3729 4005
Email address
mohammadsharifi.ghasem@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-03, 1400/11/14
Expected recruitment end date
2022-03-05, 1400/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy and safety of autologous blood injection with c-clamp vascular closure device in treatment of iatrogenic pseudoaneurysm after femoral artery puncture
Public title
Autologous blood transfusion with mechanical compression in the treatment of iatrogenic pseudoaneurysm of the femoral artery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with pseudoaneurysm of the femoral artery following angiography
Pseudoaneurysm size larger than 2 cm
Patient consent to enter the study
Exclusion criteria:
Active infection of the groin area
Hematoma larger than 2 cm on ultrasound
Skin necrosis
Symptoms of lower limb ischemia
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Esfahan University of Medical Sciences, Hezar Jarib Ave., Esfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-02-06, 1399/11/18
Ethics committee reference number
IR.MUI.MED.REC.1399.1026
Health conditions studied
1
Description of health condition studied
Iatrogenic pseudoaneurysm of the femoral artery
ICD-10 code
S75.0
ICD-10 code description
Injury of femoral artery
Primary outcomes
1
Description
Success of the treatment method in closing pseudoaneurysm
Timepoint
24 hours and one week after interventions
Method of measurement
By ultrasound
2
Description
Complications of treatment
Timepoint
24 hours and one week after interventions
Method of measurement
Examination of patients
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients in this group, after diagnosis of femoral artery pseudoaneurysm, under mechanical compression by C-clamp, the pressure of which is marked under the ultrasound guide, and then the amount of pressure applied to the site of the sheath is applied. That homeostasis is established while the distal pulse of the lower limb is palpable. The rate of improvement and treatment complications in patients are evaluated.
Category
Treatment - Devices
2
Description
Intervention group 2: Patients in this group, after diagnosis of pseudoaneurysm of the femoral artery, 10 to 20 cc of the patient's blood is injected by the same sonographer according to the sonographer's estimate of the sac volume after clot formation under the ultrasound guide in sterile conditions in the pseudoaneurysm sac. The rate of improvement and treatment complications in patients are evaluated.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran hospital
Full name of responsible person
Mohmmad Hadi Mansouri
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave,. Daneshgah Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673118
Phone
+98 31 3668 0048
Email
haghjoo.sh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Hadi Mansouri
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Hadi Mansouri
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Hadi Mansouri
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Website of the Research Committee of Isfahan University of Medical Sciences
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.