Evaluation of the effect of tranexamic acid on homeostasis after tibial osteotomy
Design
This study is a randomized clinical trial (quadruple blocks) without blinding, which will be performed in parallel groups with the participation of 120 patients who will be divided into three equal groups.
Settings and conduct
This study will be performed without blinding and in Imam Reza Hospital of Tabriz with the participation of 120 patients candidate for tibial osteotomy; Patients will be divided into three equal groups; Topical tranexamic acid will be used for one group and intravenous tranxamic acid for another; Normal saline serum will be used as a placebo for the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria will include: osteoarthritis of the knee joint and a candidate for surgery, and exclusion criteria will also include: previous history of knee surgery, homeostasis disorders, use of blood thinners, history of venous thrombosis Depth and pathology will be on the outside of the knee.
Intervention groups
This study is a randomized clinical trial without blinding which will be performed to evaluate the effect of tranexamic acid on homeostasis after tibial osteotomy in 120 patients referred to Imam Reza Hospital in Tabriz. Patients will be divided into three equal groups and one will use topical tranexamic acid and the other will use intravenous tranexamic acid; Normal saline serum will be used as a placebo for the control group.
Main outcome variables
Bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N25
Registration date:2022-01-05, 1400/10/15
Registration timing:prospective
Last update:2022-01-05, 1400/10/15
Update count:0
Registration date
2022-01-05, 1400/10/15
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-20, 1400/10/30
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of tranexamic acid on homeostasis after tibial osteotomy
Public title
Effect of tranexamic acid on homeostasis after tibial stereotomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Osteoarthritis of the knee joint
Candidate for surgery
Exclusion criteria:
History of previous knee surgery
Disorders of homeostasis system
Taking blood thinners
History of deep vein thrombosis
Pathology in the outer part of the knee
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided into four groups by quadruple block method; For this purpose, 4 sheets of paper were prepared and the letter A was written on two sheets and the letter B was written on the sheet; The sheets were then placed in a sealed container and each patient who came was given one of the sheets by the statistical consultant and the person was divided into two groups based on it.
Blinding (investigator's opinion)
Not 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 Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2020-09-07, 1399/06/17
Ethics committee reference number
IR.TBZMED.REC.1399.607
Health conditions studied
1
Description of health condition studied
Bleeding
ICD-10 code
D59.6
ICD-10 code description
Hemoglobinuria due to hemolysis from other external causes
Primary outcomes
1
Description
Bleeding
Timepoint
Every six hours to 72 hours after surgery
Method of measurement
View blood storage drains
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group(1): This group will be given 15 kg / mg tranexamic acid as an intravenous infusion over 20 minutes and then a full intravenous infusion at a dose of 1 mg / kg per hour until the end of surgery.
Category
Treatment - Drugs
2
Description
Intervention group(2): In this group, topical tranexamic acid will be injected. In this group, 500 mg of traxamic acid will be injected at the surgical site 15 minutes before the start of surgery.
Category
Treatment - Drugs
3
Description
Control group: Fifteen milliliters of normal saline will be given to this group as an intravenous infusion over 20 minutes, followed by a full intravenous infusion at a dose of one milliliter per hour until the end of surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Jafar Solei,anpour Mokhtarmanand
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
6165665631
Phone
+98 21 3335 5921
Email
mkhanbabayi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Tabriz University of Medical Sciences, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3333 5986
Email
Mkhanbabayi@yahoo.com
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
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
Tabriz University of Medical Sciences
Full name of responsible person
Jafar Soleimanpour Mokhtarmanand
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Mkhanbabayi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Gholamreza Khorrami
Position
Doctor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
GH_khorami@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available