General purpose:
Comparative study of vascular complications related to arterial sheet extraction using clamp ease and hand pressure in patients undergoing angiography admitted to the Post Angiography ward of Shahid Chamran Hospital in Isfahan in 1400.
Design
Experimental study and clinical trial. No blinding. Random sample allocation and 94 samples and file number with even and patient file numbers were used for randomization.
Settings and conduct
This study was conducted for the first time in Iran and before that in the United Kingdom as a systematic review and based on previous studies, the manual method had more complications. In this study, blinding was not performed.
Participants/Inclusion and exclusion criteria
Having the consent to participate in the study
Normal international ratio (less than 1.8)
Has not had a surgical incision on the femoral artery in the past week. (35)
Use the minimum dose of heparin (less than 5000) units during angiography (36)
In other centers, it has not received anticoagulants (reteplase, streptokinase, altplase) (7).
Absence of previous hematoma and ecchymosis during the angiographic procedure in Cat Lab or during recent hospitalization
No osteoporosis
Undergo angiography through the femoral artery.
The process of implantation of arterial sheet and angiography of the patient should be performed by a specific doctor.
Lack of history of femoral and pelvic surgeries, including femoral head replacement and pelvic bone fractures
Intervention groups
Removal of arterial sheet after angiography is done in two general ways: sheet removal with the help of hand (usual method and control group) and method of using clampease tool (intervention group) in many cardiovascular centers. Vascular complications after sheet removal It is examined in these two groups.
Main outcome variables
Hemorrhage; hematoma; ecchymosis; Homeostasis time
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20211121053121N2
Registration date:2021-12-04, 1400/09/13
Registration timing:prospective
Last update:2021-12-04, 1400/09/13
Update count:0
Registration date
2021-12-04, 1400/09/13
Registrant information
Name
Seyed Abbas Hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7504
Email address
a_hoseini@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-06, 1400/09/15
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative of vascular complications related to arterial sheet extraction using clamp ease and hand pressure in patients undergoing angiography.
Public title
Comparative study of vascular complications related to arterial sheet extraction using clamp ease device and hand pressure in patients undergoing angiography.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent to participate in the study
International normal ratio less than 1.8
had not a surgical incision on the femoral artery in the past week. (35)
Use the minimum dose of heparin (less than 5000) units during angiography (36)
The patient has not received anticoagulants in other centers (rateplase, streptokinase, altplase) (7).
Absence of previous hematoma and ecchymosis during the angiographic procedure in Cat Lab or during recent hospitalization (35)
The patient should not have osteoporosis (37)
The patient underwent angiography through the femoral artery.
The process of implantation of arterial sheet and angiography of the patient should be performed by a specific doctor.
Lack of history of femoral and pelvic surgeries, including femoral head replacement and pelvic bone fractures (38)
Exclusion criteria:
Does not exist
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, initial sampling is easy and sample allocation between the two groups is done randomly so that patients with Odd file number (patients with the last digit of individual file number) in the group of arterial sheet exit by hand and patients with Even file number (patients with the last digit of the even number) are in the group of using the clamp ease device.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is an experimental study with two groups (manual method group and clampase method group) randomly and prospectively during which two groups of patients a doctor is randomly selected and divided into groups with hand pressure and the group using clampase device.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib St., Isfahan University of Medical Sciences, School of Nursing, Management and Rehabilitation
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-10-30, 1400/08/08
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.177
Health conditions studied
1
Description of health condition studied
This study is performed in the field of vascular injuries after the invasive action of arterial sheet removal
ICD-10 code
I51.6
ICD-10 code description
cardiovascular disease NOS
Primary outcomes
1
Description
The primary variables hemorrhage
Timepoint
The initial outcome of bleeding is assessed immediately after the sheet is removed; 15 minutes later; 30 minutes later; 45 minutes later; 1 hour later; 2 hours later; 4 hours later: 8 hours later: 12 hours later; 24 hours later.In total, it is examined in 10 steps.
Method of measurement
Measurement of bleeding volume is checked with a DM3 digital scale with an error level of 0.01 mg.
2
Description
Primary outcome of hematoma
Timepoint
The initial outcome of hematoma is assessed immediately after the sheet is removed; 15 minutes later; 30 minutes later; 45 minutes later; 1 hour later; 2 hours later; 4 hours later: 8 hours later: 12 hours later; 24 hours later.In total, it is examined in 10 steps.
Method of measurement
Hematoma outcome is measured by calculating the area of the hardened area by hand with using a standard transparent ruler.
3
Description
Primary outcome of vascular ecchymosis
Timepoint
The initial outcome of ecchymosis is assessed immediately after the sheet is removed; 15 minutes later; 30 minutes later; 45 minutes later; 1 hour later; 2 hours later; 4 hours later: 8 hours later: 12 hours later; 24 hours later.In total, it is examined in 10 steps.
Method of measurement
The outcome of ecchymosis is measured by calculating the area of skin discoloration to bruising without stiffness when touched by hand using a standard transparent ruler.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group consists of 47 patients of a specific physician who refer to the angiography department on an outpatient basis for angiography.In this group, which are randomly selected and available, one of the types of Vascular closing devices (VCDs) available in Iran, which was made in California, USA in 2005 and widely distributed around the world, including Shahid Chamran Hospital in Isfahan. Used to exit the sheet.This device, which includes a flat plate to be placed under the patient, a height-adjustable base that can be changed depending on the patient's thigh size, and a transparent sterile plate that is changed from patient to patient to reduce the risk of disease transmission.In both Method, after the necessary training, we proceed to remove the arterial sheet. After removing the sheet, the clamp device is fixed on the patient's artery. After 20 minutes, if there is no bleeding, the device returns completely and the patient is examined for bleeding Hematoma and ecchymosis are evaluated.for 24 hours. Another method is to remove the arterial sheet: The manual method is to remove the sheet, which is the usual method of removing the sheet, which is similar to the previous method. To ensure the absence of bleeding, the hand pressure is removed and the patient is examined for hematoma bleeding and ecchymosis for 24 hours.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Dr. Chamran Heart Specialized Hospital
Full name of responsible person
Syed Abas Hoseini
Street address
Hezar Jerib St., Isfahan University of Medical Sciences, School of Nursing, Management and Rehabilitation
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7504
Email
a-hoseini@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mansour Siavash
Street address
Hezar Jerib St., Isfahan University of Medical Sciences, School of Nursing, Management and Rehabilitation
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3973 0303
Email
sh_haghjoo@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
Isfahan University of Medical Sciences
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
Shahid Dr. Chamran Cardiovascular Research Institute, Isfahan
Full name of responsible person
Dr. Alireza Khosravi
Street address
Isfahan, Mushtaq 3rd St., after Shahrestan Bridge, next to Shahid Chamran Heart Training Center, Shahid Rahmani Alley, Isfahan Cardiovascular Research Institute
City
Esfahan
Province
Isfehan
Postal code
فاقد کد پستی است
Phone
+98 31 3611 5216
Email
alirezakhosravica.mui.ac@gmail.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Dr. Chamran Cardiovascular Research Institute, Isfahan
Proportion provided by this source
10
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
3
Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan School of Nursing and Midwifery
Full name of responsible person
Dr. Maryam Kianpour
Street address
Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, School of Nursing and Midwifery
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7532
Email
kianpour@mail.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Isfahan School of Nursing and Midwifery
Proportion provided by this source
40
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
Isfahan University of Medical Sciences
Full name of responsible person
Syed Abas Hosseini
Position
Faculty member of Isfahan University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Responsible for the skills laboratory of the School of Nursing and Midwifery
Street address
Hezar Jerib St., Isfahan University of Medical Sciences, School of Nursing, Management and Rehabilitation
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7504
Email
a-hoseini@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Syed Abas Hoseini
Position
Faculty member of Isfahan University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Responsible for the skills acquisition laboratory of Isfahan School of Nursing and Midwifery
Street address
Hezar Jerib St., Isfahan University of Medical Sciences, School of Nursing, Management and Rehabilitation
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7504
Email
a-hoseini@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Syed Abas Hoseini
Position
Faculty member of Isfahan University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Responsible for the skills acquisition laboratory of Isfahan School of Nursing and Midwifery
Street address
Hezar Jerib St., Isfahan University of Medical Sciences, School of Nursing, Management and Rehabilitation
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7504
Email
a-hoseini@nm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
I have not decided yet, but if you agree, I have no problem with publishing the data
When the data will become available and for how long
I have not decided yet, but if you agree, I have no problem with publishing the data
To whom data/document is available
I have not decided yet, but if you agree, I have no problem with publishing the data
Under which criteria data/document could be used
I have not decided yet, but if you agree, I have no problem with publishing the data
From where data/document is obtainable
I have not decided yet, but if you agree, I have no problem with publishing the data
What processes are involved for a request to access data/document
I have not decided yet, but if you agree, I have no problem with publishing the data
Comments
I have not decided yet, but if you agree, I have no problem with publishing the data