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Comparison of intravenous injection of tranexamic acid before and at the end of surgery with no injection of the drug to control bleeding after total knee arthroplasty (TKA).

Protocol summary

Study aim
The aim of this study is comparison of the effect of tranexamic acid injection before and at the end of surgery with no injection of the drug to control of bleeding in patients under total knee arthroplasty.
Design
Clinical trial with control group, with parallel, not blinded, not randomized groups on 153 patients.
Settings and conduct
This study is a clinical trial which is performed in Shariati, Sina and Milad hospitals in Isfahan.153 patients who are eligibled for inclusion in the study are selected through convenience sampling and divided into three groups of 51. In group A: One hour before surgery, 2 ampoules of 500 mg tranexamic acid are injected intravenously, in group B: At the end of surgery, 2 ampoules of 500 mg tranexamic acid are injected intravenously and in group C: Tranexamic acid is not injected at all. The measure of bleeding is intra drain blood (24 hours after surgery). The data recorded in the questionnaire include: Study group (A, B and C), age, gender, history of blood coagulation problems, patients with underlying disease and its type, history of thrombolysis and bleeding rate.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1)need total knee arthroplasty 2)Patients compliance to participate in the study. Exclusion criteria: 1)coagulopathy 2)history of thrombophlebitis 3)history of cardiovascular and brain disease 4)Pregnancy
Intervention groups
Group A: One hour before surgery, 2 ampoules of 500 mg tranexamic acid are injected intravenously, in group B: At the end of surgery, 2 ampoules of 500 mg tranexamic acid are injected intravenously and in group C: Tranexamic acid is not injected at all. The measure of bleeding is intra drain blood (24 hours after surgery).
Main outcome variables
Effect of tranexamc acid injection on bleeding amount after total knee arthroplasty؛ Effect of injection time on bleeding amount after total knee arthroplasty.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200526047574N1
Registration date: 2020-06-17, 1399/03/28
Registration timing: registered_while_recruiting

Last update: 2020-06-17, 1399/03/28
Update count: 0
Registration date
2020-06-17, 1399/03/28
Registrant information
Name
Behnam Haghpanah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3220 2418
Email address
behnamhaghpanah@smd.iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-07, 1399/03/18
Expected recruitment end date
2020-09-08, 1399/06/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous injection of tranexamic acid before and at the end of surgery with no injection of the drug to control bleeding after total knee arthroplasty (TKA).
Public title
Effect of Tranexamic acid in reducing the bleeding of knee replacement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1)Patients need total knee replacement 2)Patients have no coagulation problems 3)Patients have no underlying disease 4)Patients have no history of thrombophlebitis 5)Patients compliance to participate in the study
Exclusion criteria:
1)Patients have coagulation problem 2)Patients have history of thrombophlebitis 3)Patients have history of cardiovascular and brain disease 4)Patients non compliance to participate in the study 5)Pregnancy
Age
From 53 years old to 84 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 153
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
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 Science
Street address
School of Medicine, Isfahan University, Azadi Square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673441
Approval date
2020-01-22, 1398/11/02
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1398.010

Health conditions studied

1

Description of health condition studied
knee replacement
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
The amount of blood collected inside the drains after surgery
Timepoint
24 hours after surgery
Method of measurement
Measuring the amount of blood collected inside the drains in cm3 (cc).

Secondary outcomes

1

Description
Observation the size of knee hemarthrosis after surgery
Timepoint
48 hours after surgery
Method of measurement
Observation and examination

Intervention groups

1

Description
Intervention group 1: 2 ampoules of 500 mg tranexamic acid, intravenously, One dose, One hour before surgery
Category
Treatment - Drugs

2

Description
Intervention group 2: 2 ampoules of 500 mg tranexamic acid, intravenously, One dose, at the end of surgery.
Category
Treatment - Drugs

3

Description
Control group: No injection of tranexamic acid
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Ali Shariati hosptal
Full name of responsible person
Dr. Behnam Haghpanah (Orthopedic surgen)
Street address
Dr. Ali Shariati hosptal, Shariati Street, Chaharbagh Bala Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8173745384
Phone
+98 31 3627 2001
Email
behnamhaghpanah42@gmail.com

2

Recruitment center
Name of recruitment center
Milad hospital
Full name of responsible person
Dr. Behnam Haghpanah (Orthopedic surgen)
Street address
Milad hospital, Shahid Bakhshi Street, Janbazan Street, Simin Cross, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8179663467
Phone
+98 31 3777 4001
Email
behnamhaghpanah42@gmail.com

3

Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Dr. Behnam Haghpanah (Orthopedic surgen)
Street address
Sina Hospital, Ghasr Cross, Shams Abadi Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8135613477
Phone
+98 31 3220 5025
Email
behnamhaghpanah42@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Dr. Ali Shariati Hospital/ Orthopedic ward
Full name of responsible person
Dr. Behnam Haghpanah (Orthopedic Surgen)
Street address
Dr. Ali Shariati Hospital, Shariati Street, Chaharbagh Bala Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8173745384
Phone
+98 31 3627 2001
Email
behnamhaghpanah42@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University, Najafabad Branch, Isfahan
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
School of medicine/Islamic Azad University, Najafabad Branch
Full name of responsible person
Anis Salimi
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
Second Floor, No. 486, Alley.1, Saadat Ave., Molana Ave., Shahrak-e Vali Asr., Janbazan Ave., Simin Cross., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174799916
Phone
+98 31 3777 3623
Email
anis.salimi2013@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Najafabad Branch
Full name of responsible person
Behnam Haghpanah
Position
Orthopedics surgen/ Associate professor of medical school
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Third Floor, No. 10, Iran Tour Alley., East Abbasabad Ave.
City
Isfahan
Province
Isfehan
Postal code
8134617551
Phone
+98 31 3220 2418
Email
behnamhaghpanah42@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
School of Medicine/Islamic Azad University, Najafabad Branch
Full name of responsible person
Anis Salimi
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
Second Floor, No. 486, Alley.1, Saadat Ave., Molana Ave., Shahrak-e Vali Asr., Janbazan Ave., Simin Cross, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174799916
Phone
+98 31 3777 3623
Email
anis.salimi2013@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
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