study of effect of local Tranexamic acid in reducing postoperative bleeding on coronary artery bypass graft
Design
This study is clinical trial and double blind. 62 patients with arterial coronary artery bypass graft referring to Amiralmomenin Arak Hospital.We divide patients in two groups randomly.
Settings and conduct
This study is clinical trial and double blind. 62 patients with arterial coronary artery bypass graft referring to Amiralmomenin Arak Hospital.We divide patients in two groups randomly.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with elective CABG referrals; ASA Class 2 and 3;
Tranexamic acid insensitivity; surgery performed by a surgeon; duration of surgery 4 to 6 hours
Exclusion criteria: Increase the duration of the operation for more than 6 hours;
cardiomegaly and CHF; going on a cardio-pulmonary pump for 2 times during operation; all patients who die during surgery; history of cardiac arrest and CPR before surgery
Intervention groups
En Intervention group: Before the separation of the pulmonary pump, patients are treated with 2 gram of Tranexamic acid in 100 milliliter and placed in the topical mediastinum of the patient by the surgeon.
Main outcome variables
We check bleeding afetr surgery, average number of Paccell received during 24 hours after surgery, average number of unit platelets received within 24 hours after surgery, average number of FFP units received within 24 hours of operation and average number of returns to the operating room to control bleeding within 24 hours of operation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N62
Registration date:2018-01-17, 1396/10/27
Registration timing:registered_while_recruiting
Last update:2018-01-17, 1396/10/27
Update count:0
Registration date
2018-01-17, 1396/10/27
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
2017-11-11, 1396/08/20
Expected recruitment end date
2019-11-11, 1398/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
study of effect of local Tranexamic acid in reducing postoperative bleeding on coronary artery bypass graft
Public title
study of effect of local Tranexamic acid in reducing postoperative bleeding on coronary artery bypass graft
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with elective CABG referrals
ASA Class 2 and 3
Tranexamic acid insensitivity
Surgery performed by a surgeon
Duration of surgery 4 to 6 hours
Exclusion criteria:
Increase the duration of the operation for more than 6 hours
cardiomegaly and CHF
Going on a cardio-pulmonary pump for 2 times during operation
All patients who die during surgery
History of cardiac arrest and CPR before surgery
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization with random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is not aware of the treatment received.Participant and Analyzer are blind (double blind).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina pectoris
Primary outcomes
1
Description
bleeding after surgery
Timepoint
after surgery
Method of measurement
score
2
Description
mean number of PACs received during 24 hours after surgery
Timepoint
24 hours after surgery
Method of measurement
count
3
Description
mean number of unit platelets received within 24 hours after surgery
Timepoint
24 hours after surgery
Method of measurement
count
4
Description
mean of number of FFP units received within 24 hours of surgery
Timepoint
24 hours after surgery
Method of measurement
count
5
Description
The average number of returns to the operating room to control bleeding within 24 hours of operation
Timepoint
24 hours after surgery
Method of measurement
count
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before the separation of the pulmonary pump, patients are treated with 2 gram of Tranexamic acid in 100 millileter and placed in the topical mediastinum of the patient by the surgeon.
Category
Treatment - Drugs
2
Description
Control group: Before the separation of the pulmonary pump, patients are treated with 100 millileter of normal saline and is topically injected into the mediastinum by the surgeon.