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Comparison of Three Methods of Hemostasis by Use of Ulnar TR Band, Manual Compression and Wrist Hyperextension in Patients Undergoing Coronary Angiography via Trans-Palmar Access

Protocol summary

Study aim
- Determine of hemostasis time in manual compression, ulnar TR band and wrist hyperextension methods in patients undergoing coronary angiography via palmar artery
Design
Three arm parallel groups, non-randomized with blinded outcome assessment.
Settings and conduct
Location: Chamran Heart Center, Isfahan, Iran. All patients candidate for coronary angiography with consent and notification were randomly divided into three groups of homeostatic control including local compression, ulnar TR band and wrist hyperextension; after coronary angiography done through palmar artery.
Participants/Inclusion and exclusion criteria
Inclusion: Candidate for coronary angiography. Exclusion: Needing angioplasty, Unstable hemodynamics and cardiogenic shock, Acute myocardial infarction, Coagulopathy and anti-coagulant, medication use with INR> 2.0, Severe renal failure (GFR <30) Raynaud disease, Carpal tunnel syndrome, The sensory and motor deficits in the hands nerve and the internal fracture of the bones wrist.
Intervention groups
First group: Palmar artery puncture site hemostasis with local compression Second group: Palmar artery puncture site hemostasis with ulnar TR band Third group: Palmar artery puncture site hemostasis with wrist hyperextension
Main outcome variables
Hemostasis time, pain severity of hemostasis site, patients satisfaction, hospitalization duration, complication occurrence.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200223046595N1
Registration date: 2020-03-23, 1399/01/04
Registration timing: retrospective

Last update: 2020-03-23, 1399/01/04
Update count: 0
Registration date
2020-03-23, 1399/01/04
Registrant information
Name
Roya Kasiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3260 3106
Email address
roya_k1988@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-01, 1396/04/10
Expected recruitment end date
2019-07-01, 1398/04/10
Actual recruitment start date
2017-07-01, 1396/04/10
Actual recruitment end date
2019-12-11, 1398/09/20
Trial completion date
2020-01-15, 1398/10/25
Scientific title
Comparison of Three Methods of Hemostasis by Use of Ulnar TR Band, Manual Compression and Wrist Hyperextension in Patients Undergoing Coronary Angiography via Trans-Palmar Access
Public title
Comparison of hemostasis in palmar angiography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who underwent diagnostic angiography through palmar artery approach
Exclusion criteria:
Need to angioplasty Unstable hemodynamics and cardiogenic shock Acute myocardial infarction Coagulopathy and anti-coagulant medication use with INR> 2.0 Severe renal failure (GFR <30) Raynaud disease Carpal tunnel syndrome The sensory and motor deficits in the hands nerve and the internal fracture of the bones wrist
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 110
Actual sample size reached: 106
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
Faculty of Medicine, Isfahan University of Medical Sciences
Street address
Hezar Jerib
City
Isfahn
Province
Isfehan
Postal code
8174673461
Approval date
2018-12-12, 1397/09/21
Ethics committee reference number
IR.MUI.MED.REC.1397.157

Health conditions studied

1

Description of health condition studied
Angiographic site hemostasis, Coronary artery diseases
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery

Primary outcomes

1

Description
Hemostasis time
Timepoint
After palmar artery sheath removal until cession of bleeding
Method of measurement
Based on minute

Secondary outcomes

1

Description
Pain severity
Timepoint
During the hamostasis method
Method of measurement
Based on VAS scale

2

Description
Hospitalization duration
Timepoint
Procedure time to discharge
Method of measurement
Based on total days

3

Description
Patients satisfaction
Timepoint
During the hemostasis methods
Method of measurement
Questionnaire

4

Description
Complication occurrence
Timepoint
During the hospitalization to 1 month after the discharge
Method of measurement
Based on physical exam

Intervention groups

1

Description
Intervention group: Local compression on palmar artery puncture site and assessment of hemostasis time
Category
Treatment - Other

2

Description
Intervention group: Use of Ulnar TR band on ulnar artery site and assessment of hemostasis time
Category
Treatment - Devices

3

Description
Intervention group: Wrist hyperextension and assessment of hemostasis time
Category
Treatment - Other

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
City
Isfahan
Province
Isfehan
Postal code
8158388994
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
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
sm.kermani@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
Roya Kasiri
Position
Cardiologist
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Salman Farsi
City
Isfahan
Province
Isfehan
Postal code
8158388994
Phone
+98 31 3260 0961
Email
roya_k1988@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
Assistant Professor of University
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Salman Farsi
City
Isfahan
Province
Isfehan
Postal code
8158388994
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
Roya Kasiri
Position
Cardiologist
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Salman Farsi
City
Isfahan
Province
Isfehan
Postal code
8158388994
Phone
+98 31 3260 0961
Email
roya_k1988@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
Not applicable
Title and more details about the data/document
Patients data and clinical outcomes will publish based on tables and paper
When the data will become available and for how long
After publication in the magazine and according to its magazine and publisher rules
To whom data/document is available
Researchers
Under which criteria data/document could be used
Clinical use
From where data/document is obtainable
Email
What processes are involved for a request to access data/document
After publication, via email request to correspondence author and according to its magazine and publisher rules
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