Withholding vs Maintaining aspirin prior to coronary artery bypass graft surgery; a Clinical Trial Study
Design
The double blind randomized clinical trial, consisted of 204 patients who are randomly divided into 2 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
The study population are patients with coronary artery bypass graft surgery, attending Amiralmomenin hospital in Arak who are divided into 4 groups by simple randomization using envelopes. The study is double-blind in which outcome evaluator, data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all patients who die during surgery, all patients who come to the operating room for the first time for coronary artery bypass graft, all patients undergoing open heart surgery by a surgeon, all patients are brought to the operating room electively
Exclusion criteria: patients who develop cardiac and respiratory arrest during surgery, all patients who die during surgery
Intervention groups
In the first group, aspirin will continue until the day of surgery, and in the second group, it will be stopped 48 hours before the operation.
Main outcome variables
Bleeding, mean number of postoperative FFP, mean postoperative cardiac tamponade, mean postoperative myocardial infarction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N150
Registration date:2020-10-31, 1399/08/10
Registration timing:registered_while_recruiting
Last update:2020-10-31, 1399/08/10
Update count:0
Registration date
2020-10-31, 1399/08/10
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Withholding vs Maintaining aspirin prior to coronary artery bypass graft surgery; A Clinical Trial Study
Public title
Withholding vs Maintaining aspirin prior to coronary artery bypass graft surgery; A Clinical Trial Study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who die during surgery
All patients who come to the operating room for the first time for coronary artery bypass graft
All patients undergoing open heart surgery by a surgeon
All patients are brought to the operating room electively
Exclusion criteria:
Patients who develop cardiac and respiratory arrest during surgery
All patients who die during surgery
Age
From 35 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
204
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random allocation with envelopes in 2 groups A and B .
In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is clinical trial.Outcome elevator and analyzer and participant are blind (double blind).Outcome elevator and analyzer and participant don't aware from grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2018-12-12, 1397/09/21
Ethics committee reference number
IR.ARAKMU.REC.1397.209
Health conditions studied
1
Description of health condition studied
Coronary artery bypass graft surgery
ICD-10 code
I25.700
ICD-10 code description
Atherosclerosis of coronary artery bypass graft(s), unspecified, with unstable angina pectoris
Primary outcomes
1
Description
Bleeding
Timepoint
During operation
Method of measurement
Observation
2
Description
Mean number of postoperative FFP
Timepoint
After surgery
Method of measurement
Observation
3
Description
Mean postoperative cardiac tamponade
Timepoint
After surgery
Method of measurement
Observation
4
Description
Mean postoperative myocardial infarction
Timepoint
After surgery
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first group, aspirin will continue until the day of surgery.
Category
Treatment - Drugs
2
Description
Intervention group: In the second group, it will be stopped 48 hours before the operation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Dr Alireza Kamali
Street address
Amiralmomenin hospital, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
arjmandzadegan@arakmu.ac.ir
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
Dr Alireza rostami
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Amiralmomenin hospital, Sardasht
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street