The aim of this study is to assessing an effect of time of complete bed rest and keeps the sand bag on the rate of hemorrhage and hematoma after coronary angiography. This randomized clinical trial conducted on 222 patients undergone selective angiography which divided in 3 groups. Patients with age>18, only one trial for femoral artery access with angiography sheath 6 French was included in study and patients with any kind of coagulopathy and emergency procedures are excluded. In control group, Patients receiving routine post angiography care. (10 hours in complete bed rest by Sand bag in first 4 hours) In group A, Patients receiving 8 hours complete bed rest by using Sand bag in first 2 hours. In group B, Patients receiving 7 hours complete bed rest by using Sand bag in first 4 hours. By completing bed rest and sand bag insertion, Patients evaluated on vital sign, angiography puncture site and back pain. In This study, bleeding and hematoma are considered as a primary outcome and back pain as a secondary outcome variable.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081323609N1
Registration date:2015-11-25, 1394/09/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-25, 1394/09/04
Registrant information
Name
Khalil Rasouly
Name of organization / entity
Shahid Sadoughi University Of Medical Sciences and Health Services, Yazd, Iran.
Country
Iran (Islamic Republic of)
Phone
+98 35 3725 1668
Email address
rasouly.kh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Sadoughi University of Medical Science, Yazd, Iran.
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of time of complete bed rest and keep the sand bag on the rate of hemorrhage and hematoma after coronary angiography.
Public title
The effect of time of complete bed rest and keep the sand bag on the rate of hemorrhage and hematoma after coronary angiography.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: were are considered, All patients undergoing transfemoral cardiac catheterization by six French sheath and transferred to ward; age>18 and patients by one puncture trial for femoral artery access.
Exclusion criteria: were considered; patients receiving anticoagulant by INR>; age>75; previous history of angiography; chronic lower back pain; previous surgery in the Iliac or Femoral arteries; abnormal prothrombin time(PT>90) and platelet lower than 100000.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
222
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization is done by table of random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciense, Yazd, Iran.
Street address
Nursing and Midwifery College, Boo Ali Street, Safaee, Yazd.
City
Yazd
Postal code
Approval date
2015-08-23, 1394/06/01
Ethics committee reference number
ir.ssu.rec.1394.69
Health conditions studied
1
Description of health condition studied
Bleeding
ICD-10 code
D69.9
ICD-10 code description
Haemorrhagic condition, unspecified
2
Description of health condition studied
Back pain
ICD-10 code
M54.9
ICD-10 code description
Dorsalgia, unspecified
Primary outcomes
1
Description
Bleeding
Timepoint
1. Immediately after angiography procedure. 2. every 15 minute in first hour. 3. every 30 minute in second hour. 3. every hour still mobilization.
Method of measurement
Amount of bleeding is measured by weight of blood loaded gauze.
2
Description
size of hematoma
Timepoint
1,2,4 and 6 hour after mobilization
Method of measurement
pulpable mass on angiography puncture site which measered by teransparent ruler.
Secondary outcomes
1
Description
Back pain
Timepoint
1,2,4,6,8 and 10 hour after angiography procedure.
Method of measurement
Visual analog scale is used for back pain assessment
Intervention groups
1
Description
In control group, Patients receiving routine post angiography care.(10 hours in complete bed rest by Sand bag in first 4 hours).
Category
Prevention
2
Description
In group A, Patients receiving 8 hours complete bed rest by using Sand bag in first 2 hours.
Category
Prevention
3
Description
In group B, Patients receiving 7 hours complete bed rest by using Sand bag in first 4 hours.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
َAfshar heart center, Yazd, Iran.
Full name of responsible person
Khalil Rasouly
Street address
Afshar heart center, Yazd, Iran.
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Sadoughi University of Medical Science, Yazd, Iran.
Full name of responsible person
Amir Houshang Mehrparvar
Street address
Nursing and Midwifery College, Boo Ali Street, Safaee, Yazd.
City
Yazd
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, Shahid Sadoughi University of Medical Science, Yazd, Iran.
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
Shahid Sadoughi University of Medical Science, Yazd, Iran.
Full name of responsible person
Khalil Rasouly
Position
Master of Sciences in Intensive Care Nursing.
Other areas of specialty/work
Street address
Nursing and Midwifery College, Boo Ali Street, Safaee, Yazd.
City
Yazd
Postal code
Phone
+98 35 3824 1751
Fax
Email
khalilrasouly@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Science, Yazd, Iran.
Full name of responsible person
Khalil Rasouly
Position
Master of Science in Intensive Care Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery College, Boo Ali Street, Safaee, Yazd.
City
Yazd
Postal code
Phone
+98 35 3824 1751
Fax
Email
khalilrasouly@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)