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Comparison the influence of sand bag and closure pad on vascular complication of patients undergoing Angiography and admitted at Imam Ali Hospital (2015)

Protocol summary

Summary
Study design: Randomized Using random draw, patients are placed in one of the groups Study population: patients undergoing coronary angiography The main criteria for inclusion: full consciousness, the use of the right femoral artery, aged between 18-80 years, the lack of bleeding disorders, and lack of groin infection, normal coagulation tests (PT, PTT, and INR), not receiving anticoagulant and glomerular filtration rate above 50 mg / dl. Main exclusion criteria:primary hemostasis more than 30 minutes Sample size: 250 In the intervention and control group the closure pad and sand bag will be used respectively. Vascular complications in both groups will be monitored, immediately and up to 24 hours after homeostasis. Intervention: in intervention group one of two groups of pregnant women using sand bags blocking pad, placed. Vascular complications in both groups, will be monitored immediately and until 24 hours after homeostasis. Randomization: Random allocation Intervention time: after completion of angiography Primary outcome: : the amount of hematoma and bleeding at the angiography site

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201404134736N5
Registration date: 2015-08-19, 1394/05/28
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-08-19, 1394/05/28
Registrant information
Name
Alireza Khatony
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3827 9394
Email address
akhatony@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the influence of sand bag and closure pad on vascular complication of patients undergoing Angiography and admitted at Imam Ali Hospital (2015)
Public title
Comparison of sand bag and closure pad on the reducing bleeding and hematoma
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: non-emergency angiography, full consciousness, the use of the right femoral artery for vascular access, age between 18-80 years, the use of sheath No. 6 (fr), the absence of pregnancy and lactation in females, absence of disorder bleeding disorder such as hemophilia, lack of infection of the groin, no peripheral arterial diseases such as Raynaud's, normal blood pressure, normal blood coagulation tests (PT, PTT, INR), not receiving anticoagulant and glomerular filtration rate above 50mg/dl respectively. Exclusion criteria: the primary hemostasis more than 30 minutes
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: 250
Randomization (investigator's opinion)
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
Ethic Committee of Kermanshah University of Medical Sciences
Street address
Shahid Beheshty Blvd., Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2015-06-23, 1394/04/02
Ethics committee reference number
kums.rec.1394.30

Health conditions studied

1

Description of health condition studied
Coronary Artery Diseases
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease Coronary (artery): • atheroma • atherosclerosis • disease • sclerosis

Primary outcomes

1

Description
amount of bleeding
Timepoint
Immediately after angiography and every half an hour up to 24 hours.
Method of measurement
Weighing gases of angiography site

2

Description
Hematoma size
Timepoint
Immediately after angiography and every 6 hours up to 24 hours
Method of measurement
Checkered ruler

Secondary outcomes

empty

Intervention groups

1

Description
Intervention 1: closure pad will be used. In this group amount of bleeding will be measured immediately and every half an hour for 24 hours and hematoma size will be measured immediately and every 6 hours for 24 hours
Category
Prevention

2

Description
Intervention 2: Sand bag will be used. In this group amount of bleeding will be measured immediately and every half an hour for 24 hours and hematoma size will be measured immediately and every 6 hours for 24 hours.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Mostafa Bahremand
Street address
Imam Ali Hospital
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafy
Street address
Shahid Beheshty Blvd., Kermanshah University of Medical Sciences
City
Kermanshah
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, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Khatony
Position
faculty member
Other areas of specialty/work
Street address
Ashayer Blvd., kermanshah School of Nursing and Midwifery
City
Kermanshah
Postal code
Phone
+98 83 3828 2102
Fax
Email
akhatony@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
kermanshah University of Medical Sciences
Full name of responsible person
Alireza Khatony
Position
phD
Other areas of specialty/work
Street address
Ashayer Blvd., kermanshah School of Nursing and Midwifery
City
Kermanshah
Postal code
Phone
+98 83 3828 2102
Fax
Email
akhatony@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Khatony
Position
PhD
Other areas of specialty/work
Street address
Ashayer Blvd., Kermanshah School of Nursing and Midwifery
City
Kermanshah
Postal code
Phone
+98 83 3828 2102
Fax
Email
akhatony@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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