Clopidogrel is an inhibitor of platelet aggregation. It is frequently administered to patients undergoing coronary angiography in anticipation of percutaneous coronary artery intervention. Some of these patients will go on to require an urgent operative procedure. Recent studies have shown that clopidogrel treatment before CABG is associated with increased postoperative bleeding, transfusion, and reexploration rates. Antifibrinolytic drugs, aminocaproic acid and tranexamic acid, reduce bleeding and postoperative transfusion requirements after coronary artery bypass. 80 patients scheduled for on-pump coronary artery bypass grafting that treated with clopidogrel less than 5 days before the operation participated in study. Patients were assiened to treatment with tranexamic acid (15mg/kg bolus before skin incision and 15mg/kg bolus after protamine neutralization) or placebo (saline solution of equivalent volume). post-operative bleeding,red blood cell transfusionand re-exploration rate in the first 24 h were recorded
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201309125381N8
Registration date:2013-09-21, 1392/06/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-21, 1392/06/30
Registrant information
Name
Nadia Banihashem
Name of organization / entity
Babol University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 22 38296
Email address
nbanihashem@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor of Research Babol University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of tranexamic acid on blood loss after coronary artery bypass grafting in patients treated with clopidogrel
Public title
Effect of tranexamic acid on blood loss after coronary artery bypass grafting in patients treated with clopidogrel
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients undergoing on-pump CABG who received clopidogrel with their last ingestion less than5 days preoperatively.
Exclusion criteria: previous cardiac surgery; hematocrit less than 33%; platelet count less than 100,000/mL; or allergy to tranexamic acid; renal failure(cr>2), hepatic failure; history of bleeding diasthesis; abnormal coagulation test; previous cardiac surgerry.
Age
From 36 years old to 75 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University Of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Approval date
2013-08-27, 1392/06/05
Ethics committee reference number
3012/30/ژ/پ
Health conditions studied
1
Description of health condition studied
Bleeding after CABG
ICD-10 code
T81.0
ICD-10 code description
Haemorrhage and haematoma complicating a procedure, not elsewhere classified
Primary outcomes
1
Description
bleeding after CABG
Timepoint
24 houres
Method of measurement
Measuring mediastinal drainage into the chest bottle
Secondary outcomes
1
Description
Blood and blood products transfusion after CABG
Timepoint
24 hours
Method of measurement
Measuring units of blood and blood products tranfused during and after CABG
Intervention groups
1
Description
15 mg/kg tranexamic acid was infused intravenously before surgical incision, and 15 mg/kg after protamine neutralization.
Category
Treatment - Drugs
2
Description
normal saline was infused intravenously before surgical incision, and after protamine neutralization.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Ruhani Hospital
Full name of responsible person
Dr Nadia Banihashem
Street address
City
babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor of Research Babol University Of Medical Sciences
Full name of responsible person
Dr Amrolah Mostafazadeh
Street address
Daneshgah Square, Ganjafrooz Avenue, Vice-chancellor Of Research
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor of Research Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr Nadia Banihashem
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
nbanihashem@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Nadia Banihashem
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
nbanihashem@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Nadia Banihashem
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
Web page address
nbanihashem@mubabol.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)