The effect of ice compress on prevention of hematoma in radial artery angiography in patients with acute coronary syndrome
Design
This study will be a clinical trial with a control group,with a parallel group,without blinding, randomized on120patients.To assign people to two groups, a block randomization method with a block size of4will be used
Settings and conduct
The study population will be patients undergoing radial angiography in Quds Arak Hospital.120 samples will be selected based on the inclusion and exclusion criteria of the study.By random allocation method with blocking and without blinding into 2 groups: intervention group1which ice compress with dimensions of 5*10 cm,weighing100gr and covered with sterile gauze, in2stages,the 1st stage before removing the transparent cuffed bracelet and the 2nd stage immediately after removing the transparent cuffed bracelet.In each stage, the duration of using the ice compress will be20minutes.
Intervention group2is the control group and they receive the usual care of the hospital(holding up the hand that has undergone angiography).
Participants/Inclusion and exclusion criteria
Entry conditions: informed consent, age18-80 years,platelets in the normal range,no sensitivity to cold;
Non-entry conditions: abnormal bleeding from the angiography site, non-cooperation
Intervention groups
Intervention group 1 includes patients undergoing radial angiography, who receive an ice compress covered with sterile gas in 2 stages in order to perform the intervention.
Intervention group 2 (control group) includes patients undergoing radial angiography who receive the usual care of the hospital (holding the arm that has undergone angiography)
Main outcome variables
size of the hematoma
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221030056340N1
Registration date:2022-12-07, 1401/09/16
Registration timing:prospective
Last update:2022-12-07, 1401/09/16
Update count:0
Registration date
2022-12-07, 1401/09/16
Registrant information
Name
Mahbobeh Rajabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5245 2650
Email address
mahbob.r72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-16, 1401/09/25
Expected recruitment end date
2023-02-04, 1401/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ice packs on hematoma prevention in radial artery angiography in patients with acute coronary syndrome
Public title
"Effect of Ice Compress on Hematoma Control"
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to Give Informed Consent
Age 18-80 Years
Radial Angiography and Having a Clear Cuffed Bracelet
Platelets within the normal range
INR<1.8
Not having Coagulation Problems
No Addiction
No History of Angiography in the Past Year
Not Receiving Streptokinase or Retplase in the Last Three Months
Not Sensitive to Cold
Exclusion criteria:
Unusual Bleeding from the Angiographic Site
Non-cooperation and Withdrawal from the Study
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Sealed Envelope online site will be used for the randomization process. Regarding the method of randomization, at the beginning of the study, using the above site, a random sequence of 120 cases was generated using the block method, which included 60 intervention cases and 60 control cases, and this list was kept with the epidemiologist colleague (consultant professor).After examining the entry criteria of each participant, and their eligibility, to decide on the placement of that person in each of the groups, the student contacted the advisor and based on the randomization sequence list for that person. A decision will be made.This procedure will be done for all participants (120 people) until the end, which will lead to the division of people into two completely equal and random groups, and this will keep the random sequence hidden from the patient (student), which shows the concept of concealment. Or Concealment is random in the allocation process. In addition, as mentioned above, the selection of each of 120 people for the intervention and control groups is based on the randomization sequence list and with the opinion of the epidemiologist (consultant professor).
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 Arak University of Medical Sciences
Street address
No. 20 , Moallem Ave., Vincheh., Mobarakeh
City
Mobarakeh
Province
Isfehan
Postal code
8499115431
Approval date
2022-09-11, 1401/06/20
Ethics committee reference number
IR.ARAKMU.REC.1401.197
Health conditions studied
1
Description of health condition studied
Radial Artery Angiography
ICD-10 code
I97.610
ICD-10 code description
Postprocedural hemorrhage and hematoma of a circulatory system organ or structure following a cardiac catheterization
Primary outcomes
1
Description
Prevention of hand hematoma after radial angiography
Timepoint
The area of the radial artery will be evaluated immediately after removing the cuffed transparent cuff, 2, 4, 6 hours after removing the transparent cuff and the morning after the angiography.
Method of measurement
The Christensen scale is used as a scale to evaluate the efficiency of hemostasis methods by evaluating the incidence of hematoma at different hours after the procedure.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In order to perform the intervention, an ice compress (from Sarma Zar company) with dimensions of 10 x 5 cm, weighing 100 grams and covered with sterile gauze, in two stages, the first stage before removing the cuffed transparent bracelet and the second stage The cuffed transparent bracelet will be used immediately after leaving. In each stage, the duration of using the ice compress will be twenty minutes. Before and after the intervention, hematoma formation or non-formation, its dimensions and diameter will be measured.
Category
Prevention
2
Description
Control group: Holding up the arm undergoing radial angiography.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Quds Arak Specialized and Subspecialized Hospital
Full name of responsible person
Mahboubeh Rajabi
Street address
Palestine Street, Quds Arak Specialized and Subspecialized Hospital
City
Arak
Province
Markazi
Postal code
3814179586
Phone
+98 86 3222 8061
Fax
+98 86 3222 2796
Email
GHODSHOSPITAL@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Salehi
Street address
No. 20 , Moallem Ave., Vincheh
City
Mobarakeh
Province
Isfehan
Postal code
8499115431
Phone
+98 31 5245 2650
Email
mahbob.r72@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mahboubeh Rajabi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.20 , Moallem Ave., Vincheh
City
Mobarakeh
Province
Isfehan
Postal code
8499115431
Phone
+98 31 5245 2650
Email
mahbob.r72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ameneh Yaghoobzadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Basij Square, Arak University of Medical SciencesMarkazi Province
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3526
Email
A.Yaghoobzadeh@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahboubeh Rajabi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 20 , Moallem Ave., Vincheh
City
Mobarakeh
Province
Isfehan
Postal code
8499115431
Phone
+98 31 5245 2650
Email
mahbob.r72@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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