Comparison study of Celox powder and standard dressing in control of bleeding from coronary angiography location in Shahid Beheshti Hospital of Qom during 2012
In this study, 50 patients in the control group and 50 patients in case group will be studied.
The patients will be selected from the candidates for coronary angiography and angioplasty in the heart center of Shahid Beheshti hospital of Qom and will be assigned randomly to two groups of case(receiving 2g Celox powder) and control (normal pressure dressings).
An informed written consent is obtained from the patients and age, gender, time to stop bleeding, underlying disease, anticoagulation medication, weight and hematoma will be recorded in all patients. After stopping the bleeding, severity of angiography location pain is determined by 5 degree Likert scale (very high, high, medium, low and very low) that is recorded based on the pain expressed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202209084N1
Registration date:2012-07-26, 1391/05/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-26, 1391/05/05
Registrant information
Name
Vahid Damanpak
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 1612 2952
Email address
vdamanpak@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Cost of drug supply: Deniz Daroo Darman Co.Other costs : Qom University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison study of Celox powder and standard dressing in control of bleeding from coronary angiography location in Shahid Beheshti Hospital of Qom during 2012
Public title
Control of bleeding caused by the use of angiography in powder celox
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Personal satisfaction of patients, patients candidates for coronary angiography for diagnosis or treatment (angioplasty)
Exclusion criteria: Lack of personal satisfaction of patients for using celox powder, severe skin allergy
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Qom University of Medical Sciences
Street address
Qom, Shahid Lavasani's Street, Qom University of Medical Sciences
City
Qom
Postal code
3719976739
Approval date
2011-09-28, 1390/07/06
Ethics committee reference number
د/4171
Health conditions studied
1
Description of health condition studied
Injury, poisoning and certain other consequences of external causes
ICD-10 code
S70-79
ICD-10 code description
Injuries to the hip and thigh
Primary outcomes
1
Description
Hemostasis
Timepoint
Till stopping bleeding
Method of measurement
With Cronometer
Secondary outcomes
1
Description
The severity of andiography location's pain
Timepoint
6 hours after stopping bleeding
Method of measurement
With 5 degree Likert scale
2
Description
Hematoma
Timepoint
1 hour and 6 hours after stopping bleeding
Method of measurement
Observation of Edema and palpation of angiography location
Intervention groups
1
Description
The patients of case group will receive 2gr Celox powder, made by MedTrade Products Ltd on the angiography location and then hand pressure will be performed. Age, gender, time to stop bleeding, underlying disease, anticoagulation medication, weight and hematoma will be recorded in all patients. After stopping the bleeding, severity of angiography location pain is determined by 5 degree Likert scale (very high, high, medium, low and very low) that is recorded based on the pain expressed.
Category
Treatment - Drugs
2
Description
The patients of control group will receive standard dressing on the angiography location and then hand pressure will be performed. Age, gender, time to stop bleeding, underlying disease, anticoagulation medication, weight and hematoma will be recorded in all patients. After stopping the bleeding, severity of angiography location pain is determined by 5 degree Likert scale (very high, high, medium, low and very low) that is recorded based on the pain expressed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Super specialty Hospital
Full name of responsible person
Vahid Damanpak
Street address
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Education, Research and Technology of Qom University of Medical Sciences
Full name of responsible person
Ali-Reza Koohpayee, MD
Street address
University of Medical Sciences Qom, Vice chancellor for research, Lavasani St., Qom
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Education, Research and Technology of Qom 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
Qom University of Medical Sciences
Full name of responsible person
Vahid Damanpak
Position
Internal manager of Clinical Research Development Centro
Other areas of specialty/work
Street address
Qom-Shahif Lavasani's Street, Qom University of Medical Sciences
City
Qom
Postal code
Phone
+98 25 1612 2952
Fax
Email
vdamanpak@muq.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Assistant professor of Qom University of Medical Sciences
Full name of responsible person
Fakhreldin Hejazi, MD
Position
Cardiologist, Angioplasty felowship
Other areas of specialty/work
Street address
Qom
City
Qom
Postal code
Phone
+98 25 1612 2952
Fax
Email
vdamanpak@muq.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Vahid Damanpak, MD
Position
Internal manager of Clinical Research Development Center
Other areas of specialty/work
Street address
Qom, Shahid Beheshti Bullward, Shahid Beheshti Hospital, Clinical Research Development Center
City
Qom
Postal code
Phone
+98 25 1612 2952
Fax
Email
vdamanpak@muq.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)