To compare the complications of two hemostasis methods (classic and patent) after transradial coronary angiography
Design
Clinical trial consists of two parallel groups, nonblinded, randomized
Settings and conduct
Location: BU-ALI Hospital, Qazvin, Iran. The number of 234 patients undergo transradial angiography. After that, the patients are randomly divided to 2 equal groups for hemostasis. In the first group, hemostasis is performed by classic method, and it is done by patent method in second group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients candidate for coronary arteries angiography
Exclusion criteria: Unstable hemodynamic; Severe renal failure; Fracture of the bones wrist; Raynaud disease; Carpal tunnel syndrome; Coagulation disorders
Intervention groups
To perform homeostasis, in first group, classic method is applied and in second group, patent method is applied.
Main outcome variables
Incidence of radial artery occlusion; Hemostasis time; Mean of pain score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210305050585N1
Registration date:2021-05-07, 1400/02/17
Registration timing:registered_while_recruiting
Last update:2021-05-07, 1400/02/17
Update count:0
Registration date
2021-05-07, 1400/02/17
Registrant information
Name
Ahmad Kiarad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
dr.ahamdkiarad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the complications of two hemostasis methods (classic and patent) in patients undergoing transradial coronary angiography
Public title
Comparison of the complications of two hemostasis after transradial coronary angiography
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate for transradial coronary arteries angiography
Exclusion criteria:
Unstable hemodynamic
Severe renal failure
Fracture of the bones wrist
Raynaud disease
Carpal tunnel syndrome
Coagulation disorders
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
234
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of individuals to study groups was done in a randomized block method using 4 blocks. This work was done with "https://app.studyrandomizer.com". In each block, there were 2 people belonging to group A and two people belonging to group B. In each block, number of treatment group and control group is equal and situation of each block with other block is different. With using opaque envelopes, sealed, sequentially numbered which recorded each of the random sequences created on a card and the cards are placed in the letter envelopes in order.
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 Qazvin University of Medical Sciences
Street address
Shahid Beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
1391134156
Approval date
2020-04-25, 1399/02/06
Ethics committee reference number
IR.QUMS.REC.1399.022
Health conditions studied
1
Description of health condition studied
Homeostasis methods in coronary arteries angiography
ICD-10 code
I25
ICD-10 code description
Chronic ischemic heart disease
Primary outcomes
1
Description
Incidence of radial artery occlusion
Timepoint
2, 4 and 6 hours after angiography
Method of measurement
Clinical examination
Secondary outcomes
1
Description
Hemostasis time
Timepoint
After radial artery sheath removal until cession of bleeding
Method of measurement
Based on minute
2
Description
Mean of pain score
Timepoint
Immediately,1 hour and 4 hours after angiography
Method of measurement
Based on VAS scale
Intervention groups
1
Description
Intervention group: In classic hemostasis method, homeostasis is performed by using an inflatable air filled wrist bracelet named as TR band at the distal forearm and radial artery site. At first, TR cuff is blowing with 15 cc of air until the radial artery blood flow was completely stopped. When primary hemostasis is occurred, TR cuff pressure is reduced and the band is removed.
Category
Treatment - Other
2
Description
Intervention group: In patent hemostasis method, homeostasis is performed by using an inflatable air filled wrist bracelet named as TR band at the distal forearm and radial artery site. At first, TR cuff is blowing with 15 cc of air until the radial artery blood flow was completely stopped. After that, TR cuff pressure is reduced (in about 10 cc air) until a little bit of blood leakage and patient was placed under supervision as long as primary hemostasis.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu-Ali Sina Hospital
Full name of responsible person
Ahmad kiarad
Street address
Department of Cardiology, Bu-Ali Sina Hospital, Bu-Ali Blvd
City
Qazvin
Province
Qazvin
Postal code
1391134156
Phone
+98 28 3333 6001
Email
dr.ahmadkiarad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Emamjomeh
Street address
Research Department of Qazvin University of Medical Sciences, Shahid beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3333 7006
Email
research.dpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Ahmad Kiarad
Position
Resident of cardiology
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Department of Cardiology, Bu-Ali Sina Hospital, Bu-Ali Blvd
City
Qazvin
Province
Qazvin
Postal code
1391134156
Phone
+98 28 3333 6001
Email
dr.ahmadkiarad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Majid Hajikarimi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Department of Cardiology, Bu-Ali Sina Hospital, Bu-Ali Blvd
City
Qazvin
Province
Qazvin
Postal code
1391134156
Phone
+98 28 3333 6001
Email
m.hajikarimi@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Ahmad Kiarad
Position
Resident of cardiology
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Department of Cardiology, Bu-Ali Sina Hospital, Bu-Ali Blvd
City
Qazvin
Province
Qazvin
Postal code
1391134156
Phone
+98 28 3333 6001
Email
dr.ahmadkiarad@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
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
Yes - There is 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