: A Study on the Effect of 2g Vancomycin paste with 200mg Tranexamic acid Ampoule Compared to Vancomycin with Distilled Water in Reducing Bleeding Amount After Coronary Bypass Surgery
Determination of the effect of dough made of 2 g vancomycin with 200 mg tranexamic acid ampoule compared to vancomycin with distilled water in reducing bleeding after coronary artery bypass graft surgery
Design
Patients were randomly divided into two control and intervention groups (n = 50); phase 3; clinical trial.
Settings and conduct
The study was performed in Chamran hospital of Isfahan. Vancomycin paste was used on the sternum bone in intervention group after open heart surgery. Postoperative bleeding was measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 35 to 80 years of age, elective CABG surgery, and patient satisfaction to participate in the study. Exclusion criteria: coagulation disorder (platelet less than 100,000), receiving heparin and other anticoagulants 48 hours before surgery, taking antiplatelet drugs 5 days before surgery, history of taking non-steroid anti-inflammatory drugs within 3 days before the operation, And those with a history of renal failure and thrombosis
Intervention groups
Before sternum closure, vancomycin + tranexamic paste was applied to the sternum bone (in the intervention group) and vancomycin + normal saline paste to the sternum bone (control group).
Main outcome variables
Volume of bleeding; Volume of injected blood products
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190714044205N1
Registration date:2020-02-18, 1398/11/29
Registration timing:retrospective
Last update:2020-02-18, 1398/11/29
Update count:0
Registration date
2020-02-18, 1398/11/29
Registrant information
Name
Hafez Asadolahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3261 6613
Email address
hafez.perfusion96@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
: A Study on the Effect of 2g Vancomycin paste with 200mg Tranexamic acid Ampoule Compared to Vancomycin with Distilled Water in Reducing Bleeding Amount After Coronary Bypass Surgery
Public title
effect of tranexamic acid in reducing bleeding after coronary bypass surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
selective CABG surgery
Patient satisfaction to participate in the study
Exclusion criteria:
coagulation disorder
receive heparin and other anticoagulants 48 hours before surgery
history of renal failure and thrombosis
taking antiplatelet drugs within 5 days before surgery
Age
From 35 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Using random allocation software and simple randomization method, 50 eligible patients were assigned into two groups of 25 (control group (vancomycin + normal saline) and intervention group (vancomycin + tranexamic acid). Random assignment by counseling The project statistic was done and finally the codes produced were given by the surgeon assistant who was responsible for the composition of the drugs. The surgeon and the outcome evaluator after surgery only had access to the codes.
Blinding (investigator's opinion)
Double blinded
Blinding description
After preparation of vancomycin paste made with tranexamic acid or normal saline, the paste was given to the surgeon without any information about the content. Paste was used by the surgeon on the sternum bone and the data were collected by an evaluator without any information about the type of paste.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
West Tulip Blvd Koi Alikhani Mother Apartment
City
esfahan
Province
Isfehan
Postal code
8158988994
Approval date
2019-07-13, 1398/04/22
Ethics committee reference number
ir.mui.med.rec.1398.187
Health conditions studied
1
Description of health condition studied
Bleeding after open heart surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bleeding
Timepoint
12-24-48 hours after surgery
Method of measurement
Via chest Buttel in icu section
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, a vancomycin 2g paste with 200 mg tranexamic acid ampoule was applied to the sternum bone.
Category
Treatment - Drugs
2
Description
Control group: Control group received two grams of vancomycin with normal saline.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Hospital
Full name of responsible person
Hafez Asadollahi
Street address
Salman Fars Hospital, Chamran Hospital
City
Esfahan
Province
Isfehan
Postal code
45213654
Phone
+98 31 3260 0012
Email
hafez.perfusion96@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Assistant Director of Research and Technology at the University.
Street address
Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
25463213
Phone
+98 31 3668 0048
Email
oloompezeshki@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hafez Asadollahi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
West Laleh Blvd Kooye Alikhani
City
Esfahan
Province
Isfehan
Postal code
245632455
Phone
+98 912 064 3032
Email
hafez.perfusion96@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Mir Mohammad Sadeghi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Chamran Hospital
City
Esfahan
Province
Isfehan
Postal code
74513441225
Phone
+98 31302610061
Email
13655631omid@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hafez Asadollahi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan, Laleh Boulevard, Koue Negarestan
City
Esfahan
Province
Isfehan
Postal code
255463541
Phone
+98 31 3261 6613
Email
hafez.perfusion96@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The first 12 hours after the first 24 hours after the operation, the first 48 hours after the operation
When the data will become available and for how long
1399
To whom data/document is available
all
Under which criteria data/document could be used
all
From where data/document is obtainable
09120643032
What processes are involved for a request to access data/document