The purpose of our study is to compare pre and post cardiopulmunary bypass tranexamic acid effect on the bleeding after coronary artery bypass graft surgery,Randomised clinical trial. In this study the researcher, the research assistant, and the participants will be blind. Bleeding due to coagulopathy after CPB(Cardio-pulmonary bypass) may cause complications and mortality. There are a lot of causes to this coagulopathy like fibrinolytic activity. Tranexamic acid(TA) leads to complex formation with plasmin and plasminogen, which prevents them from binding to fibrin. Many studies have confirmed the effect of TA in reducing post-surgical bleeding. We intend to design a clinical trial using the idea of preemptive measures on causing complications over the body, to compare the effect of TA before and after CPB on amount of bleeding after cardiac surgery.
Sixty patients who are candidates for CABG, after filling out informed consent forms, were divided into 2 groups, randomly. Before surgical incision, group 1 patients had a TA injection and patients in group 2 were injected by normal saline. After getting off the CPB, first group received normal saline and second one TA. The amount of bleeding after surgery was measured by the blood accumulated inside the chest bottle and the transfused blood units after surgery were recorded.
Our main outcome variables are the amount of bleeding.
General information
Acronym
Tranexamic acid effect
IRCT registration information
IRCT registration number:IRCT2015090723933N1
Registration date:2015-09-18, 1394/06/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-18, 1394/06/27
Registrant information
Name
Sohrab Negargar
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 3919
Email address
mosharkesh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University Of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-01-19, 1394/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pre- and post cardiopulmonary bypass tranexamic acid effect on the amount of bleeding after coronary artery bypass graft surgery
Public title
Comparison of pre- and post cardiopulmonary bypass tranexamic acid effect on the amount of bleeding after coronary artery bypass graft surgery
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: Patients under 75 years old candidate for cardiopulmunary Artery Bypass Graft surgery in the operation room of Tabriz Shahid Madani Hospital.
Exclusion criterua: Emergency surgery; Coagulopathy problems like Hemophilia, platelate below 100000 per ml, PT and PTT 1.5 times above normal range; Renal failure (Serum creatinine over 2mg/dl ); Allergy to Tranexamic acid;Existence of trombotic state (Subaracnoid Hemmorage, gallBladder disease,Vein thrombosis, Emboli); Plavix ( Clopidogrel) consumption during 7 days before operation; Streptokinase consumption during 48 hours before operation; Patients with poor heart contraction power (EF<35%); Aspirin consumption with high dose during 48 hours before operation; Repeated heart surgery operation (Redo);Active liver disease; Patients with Hb<10 g/dl
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Explained in summry
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Daneshgah Avenue
City
Tabriz
Postal code
5166615573
Approval date
2014-03-10, 1392/12/19
Ethics committee reference number
TBZMED-REC 9337
Health conditions studied
1
Description of health condition studied
Amount of bleeding in Coronary Artery Bypass Graft Surgery
ICD-10 code
I24
ICD-10 code description
Other acute ischaemic heart diseases
Primary outcomes
1
Description
Amount of bleeding
Timepoint
During operation upto discharge
Method of measurement
Amount of bleeding from chest bottle per ml
Secondary outcomes
empty
Intervention groups
1
Description
Intervention:
20mg/kg Tranexamic acid before surgical incision
Category
Prevention
2
Description
Control:
20mg/kg Tranexamic acid 10 minutes after getting Cardiopulmunary bypass
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Heart Hospital, Tabriz Department of Anestesiology, Tabriz University of Medical Scien
Full name of responsible person
Sohrab Negargar, Professor of Anesthesiology
Street address
Daneshgah Avenue
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr Sohrab Negargar
Street address
Daneshgah Avenue,Tabriz University Of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences, Shahid Madani Hospital
Full name of responsible person
Dr Sohrab Negargar
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Daneshgah Avenue- Tabriz University of Medical Sciences