Comparison of the Effect of Intravenous Tranexamic Acid on Reducing Postoperative Bleeding Volume in Patients with Complete Replacement of Knee Joint in Firoozgar Hospital during 2016 to 2018
Design
Two arm parallel group randomised trial with blinded
Settings and conduct
Subjects included patients who referred to Firoozgar Hospital clinic with knee pain. Based on the severity of articular cartilage destruction, candidates for knee arthroplasty were selected early and placed on the practice list.
The drug was administered in two ways: intra-articular and intravenous. Intravenous injection was performed 30 minutes before surgery and intra-articular injection was performed intra-articularly and after arthroplasty.
Postoperative blood volume and intraoperative hemoglobin were measured and compared.
Blindness was single blind and patients were not aware of the injection method. But the surgeon and the research team were aware of the injection form.
Participants/Inclusion and exclusion criteria
Knee Osteoarthritis
Age over 50 years
Patient's consent to participate in the study
Non-pregnancy and lactation
Absence of acute and chronic renal failure
No coagulation disorder proven
There is definitive indication for primary knee replacement surgery
Intervention groups
This study was designed to evaluate the efficacy of tranexamic acid antifibrinolytic drug in Determination the mean bleeding volume of patients undergoing knee arthroplasty. In one group the drug is injected intravenously and in the other group intravenously. The results of the injection are compared between the two groups.
Main outcome variables
Mean amount of blood lost during and after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190427043390N1
Registration date:2019-09-28, 1398/07/06
Registration timing:retrospective
Last update:2019-09-28, 1398/07/06
Update count:0
Registration date
2019-09-28, 1398/07/06
Registrant information
Name
Ali Torkaman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1301
Email address
torkaman.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
2016-09-28, 1395/07/07
Actual recruitment end date
2018-09-04, 1397/06/13
Trial completion date
2019-01-25, 1397/11/05
Scientific title
Comparison of the Effect of Intravenous Tranexamic Acid on Reducing Postoperative Bleeding Volume in Patients with Complete Replacement of Knee Joint
Public title
Tranexamic Acid in Total Knee Arthroplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with knee articular cartilage destruction that do not respond to supportive treatments
Exclusion criteria:
revision
Age
From 50 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
80
Actual sample size reached:
85
Randomization (investigator's opinion)
Randomized
Randomization description
Our aim was to place patients in groups A (intravenous) and B (intra-articular).
(AABB), (ABAB), (BAAB) and (BBAA) were plotted.
These 4 blocks were placed in a closed door package, each of which was randomly removed.
For the first 4 patients, one block was randomly removed from the envelope, and the order of the patients in the two groups followed the order of the removed block.
Blinding (investigator's opinion)
Single blinded
Blinding description
Failure to inform patients about the type of injection
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences, Vice chancellor for research, Faculty of Me
Street address
Iran University of Medical Sciences, Hemmat Highway, Next to Milad Tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-05-14, 1396/02/24
Ethics committee reference number
IR.IUMS.FMD.REC1396.9411242008
Health conditions studied
1
Description of health condition studied
primary osteoerthritis
ICD-10 code
M15.0
ICD-10 code description
Primary generalized (osteo)arthrosis
Primary outcomes
1
Description
Average amount of blood lost
Timepoint
During and after surgery
Method of measurement
Graduated cylinders in milliliters
Secondary outcomes
1
Description
deep vein thrombosis , thromboembolism
Timepoint
during 3 month post-surgical
Method of measurement
physical examination
Intervention groups
1
Description
Intervention group: Intravenous injection of one gram of single dose tranexamic acid, during ten minutes before surgery
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group: intra-articular injection of one gram of single dose tranexamic acid, 10 minutes before surgery