Comparison of two methods of homeostasis including manual compression and radial TR band in coronary angiography via snuff box method
Design
The clinical trial work consists of two parallel and single blinded non-randomized groups
Settings and conduct
Location: Shahid Chamran Heart Center, Isfahan, Iran.
80 patients under coronary angiography via snuff box method were divided into two equal groups of 40. In the first group hemostasis is performed through manual compression and in the second group using radial TR band.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Candidate for diagnostic coronary angiography, Written consent
Exclusion criteria:
Need to angioplasty, Unstable hemodynamic, acute myocardial infarction, severe renal failure, the sensory and motor deficits in the hands nerves, fracture of the bones wrist, Raynaud diseases, carpal tunnel syndrome, coagulation disorders
Intervention groups
To perform homeostasis, in first group, local compression is applied by hand and in second group, radial TR band is used.
Comparison of Manual versus Mechanical Compression methods in Hemostasis of Coronary Angiography via Snuff-Box Access
Public title
Homeostasis in angiography by snuff box method
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
candidate for diagnostic angiography and no need for angioplasty
written consent
Exclusion criteria:
Unstable hemodynamics
Acute myocardial infarction
Severe renal failure (GFR <30)
Fracture of the bones wrist
Sensory and motor deficits in the hands nerves
Raynaud diseases
Capral tunnel syndrom
Coagulation disorders
Need to angioplasty
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
74
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 Isfahan University of Medical Sciences
Street address
Hezar Jerib Street
City
Isgahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-03-04, 1398/12/14
Ethics committee reference number
IR.MUI.MED.REC.1398.658
Health conditions studied
1
Description of health condition studied
Methods of homeostasis in angiography through the snuff box artery
ICD-10 code
I25
ICD-10 code description
Chronic ischemic heart disease
Primary outcomes
1
Description
Determine of hemostasis time in coronary angiography via snuff box method
Timepoint
Just after the angiography
Method of measurement
Time (minute)
Secondary outcomes
1
Description
Mean of pain score
Timepoint
immediately,1 hour and 4 hours after angiography
Method of measurement
Visual Analuage Scale
2
Description
Neuro-vascular complications
Timepoint
During the hospitalization till 1 month after discharge
Method of measurement
Physical exam
Intervention groups
1
Description
Intervention group: In this intervention, hemostais is performed by using of local compression with hand in puncture site of snuff box artery. After passing 10 minute, the puncture site is checked foe hemostasis and the compression is done if needed. The first time of hemostasis is recorded as primary hemostasis time.
Category
Treatment - Other
2
Description
Intervention group: Intervention group: In this intervention, homeostasis is performed by using an inflatable air filled wrist bracelet named as TR band (manufactured by Lepu Medical Technology Co. Beijing, China) at the distal forearm and radial artery site. After passing 20 minute and every ten minute intervals, the wrist bracelet air was reduced to evaluation of primary hemostasis. If needed, air is injected again inside the wrist bladder. The first time of hemostasis is recorded as primary hemostasis time
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Heart Center
Full name of responsible person
Mohammad Kermani-Alghoraishi
Street address
Salman Farsi street
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۸۳۸۸۹۹۴
Phone
+98 31 3260 0961
Email
sm.kermani@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farshad Roghani-Dehkordi
Street address
Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
roghani_int@yahoo.com
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
Farshad Roghani-Dehkordi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Salman Farsi
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۸۳۸۸۹۹۴
Phone
+98 31 3260 0961
Email
roghani_int@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Kermani-Alghoraishi
Position
Assistance Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Salman Farsi
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۸۳۸۸۹۹۴
Phone
+98 31 3260 0961
Email
sm.kermani@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Kermani-Alghoraishi
Position
Assistance Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Salman Farsi
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۸۳۸۸۹۹۴
Phone
+98 31 3260 0961
Email
sm.kermani@med.mui.ac.ir
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Non-identifiable patient data including patient information and analysis in journal publications or sending to academic researchers
When the data will become available and for how long
After publishing the article according to journal rules
To whom data/document is available
Academic Researchers
Under which criteria data/document could be used
For similar researches
From where data/document is obtainable
Corresponding authors
What processes are involved for a request to access data/document