Postoperative bleeding is a common problem in cardiac surgery. We try to evaluate the effect of topical tranexamic acid (TA) on reducing postoperative bleeding of patients undergoing on pump coronary artery bypass graft (CABG) surgery.
120 isolated primary CABG patients will be included in the study. They will be divided blindly into two groups; group 1, patients receiving 1 gram TA diluted in 50 cc normal saline poured into mediastinal cavity before closing the chest and group 2 (control), patients receiving 50 ml normal saline at the end of operation. First 24 and 48 hours chest tube drainage, hemoglobin decrease and packed RBC transfusion needs will be compared.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016071628945N1
Registration date:2016-10-22, 1395/08/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-10-22, 1395/08/01
Registrant information
Name
Amir Mirmohammadsadeghi
Name of organization / entity
Isfahan Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3260 0961
Email address
am_sadeghi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Sina Hospital, Isfahan, Iran
Expected recruitment start date
2016-11-01, 1395/08/11
Expected recruitment end date
2017-11-01, 1396/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Does topical application of transexamic acid reduce postoperative bleeding in coronary artery bypass graft surgery?
Public title
Does topical application of transexamic acid reduce postoperative bleeding in coronary artery bypass graft surgery?
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients undergoing CABG surgery alone; interrupting aspirin three days and Plavix at least five days before surgery; lack of consuming any other anticoagulant drugs such as heparin or warfarin; lack of coagulation and bleeding disorders; lack of liver and kidney disease; Ejection fraction> 35%.
Exclusion criteria: complex surgery; emergency surgery; anticoagulation therapy before surgery; having hemoglobin lower than 8 grams per deciliter before surgery.
Age
From 20 years old to 90 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
randomization will be done by even and odd registration number.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Darvaze shiraz- hezar jerib street
City
Isfahan
Postal code
Approval date
2016-04-23, 1395/02/04
Ethics committee reference number
IR.MUI.REC.1395.4.13
Health conditions studied
1
Description of health condition studied
bleeding
ICD-10 code
I97.8
ICD-10 code description
Other postprocedural disorders of circulatory system, not elsewhere classified
Primary outcomes
1
Description
postoperative bleeding
Timepoint
24 hrs and 48 hrs postoperatively
Method of measurement
drainage in chest tube
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients receiving 1 gram TA diluted in 50 cc normal saline poured into mediastinal cavity before closing the chest
Category
Treatment - Drugs
2
Description
Control group: patients receiving 50 ml normal saline poured into mediastinal cavity before closing the chest
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Amir Mirmohammadsadeghi
Street address
Sina Hospital, Shamsabadi, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
investigator
Full name of responsible person
investigator
Street address
-
City
-
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
investigator
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
Isfahan University of Medical Sciences
Full name of responsible person
Amir Mirmohammadsadeghi
Position
Assistant professor
Other areas of specialty/work
Street address
HezarJerib Steet, Darvaze Shiraz
City
Isfahan
Postal code
Phone
+98 31 3260 0961
Fax
Email
am_sadeghi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Amir Mirmohammadsadeghi
Position
Assistant professor
Other areas of specialty/work
Street address
HezarJerib Steet, Darvaze Shiraz
City
Isfahan
Postal code
Phone
+98 32600961
Fax
Email
am_sadeghi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences (IUMS)
Full name of responsible person
Amir Mirmohammadsadeghi
Position
Other areas of specialty/work
Street address
Chamran Hospital, Moshtagh Sevvom
City
Isfahan
Postal code
Phone
+98 31 3260 0961
Fax
Email
am_sadeghi@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)