Use of Tranexamic Acid in the Total Knee Arthroplasty.

Knee Osteoarthritis Clinical Trial

Official title:

Evaluation of Efficacy and Safety of Perioperative Tranexamic Acid During Primary Total Knee Arthroplasty: A Randomized, Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05919615
• Other study ID #: UDMS-Orthopedics-4-2023
• Status: Completed
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: March 15, 2023

Study information

• Verified date: June 2023
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Tranexamic acid is a medication used to treat or prevent excessive blood loss during surgery. Previous studies have shown tranexamic acid (TXA) reduces blood loss and post-operative blood transfusion rate without significant complications. In addition, many meta-analyses have confirmed these results. This study also aims to determine how safe and effective tranexamic acid treatment is for different patients undergoing primary total knee arthroplasty.

Description:

Tranexamic acid (TXA) is used to control both intraoperative (IO) and postoperative (PO) bleeding during various surgical procedures. Moreover, TXA was found to indirectly reduce post-surgery infection rates and decrease hemorrhage-related mortality in trauma patients. This study aims to determine how safe and effective tranexamic acid treatment is for patients undergoing primary total knee arthroplasty. The study is a prospective, randomized, triple-blinded, placebo-controlled study. Ninety participants were enrolled between July 2021 and September 2022 and followed up with every patient for six months.

The study was done in Damascus, Syria. Participants were randomly assigned following simple randomization procedures (computerized random numbers) to 1 of 2 groups. The allocation was put into concealed envelopes independent of the surgeon and the author, and the randomization was performed by a research fellow who was not involved in patient care. Participants who went unilateral primary TKA and did not use TXA, just IV normal saline (0.9% sodium chloride), formed the control group. In contrast, the intervention group comprised participants who went primary unilateral TKA and used two-dose intravenous tranexamic acid that was applied as follows: 10mg/kg of Tranexamic Acid in 100 Milliliters（ml) normal saline (0.9% sodium chloride), the first dose 15 minutes before the tourniquet deflation and the second dose at 180 minutes after the first dosage.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with primary knee osteoarthrosis who underwent unilateral primary TKA

Exclusion Criteria:

• Known allergic reaction to tranexamic acid

• Secondary arthritis (ex., Rheumatic arthritis, traumatic arthritis, septic arthritis)

• BMI less than 20 and more than 40.

• Patients having vascular or hematologic disease.

• Patients who were taking anti-coagulant medicine and couldn't stop it.

• Patients having acute or chronic renal failure.

• Patients classified as the AAA as grade four or five.

• Patients with intra-operative complications such as intra-operative fractures or vascular injuries.

• Post-traumatic and secondary knee arthritis patients.

• Revisions and complex primary cases.

• Patients with an active infection or a history of lower limp infection.

Related Conditions & MeSH terms

• Blood Loss
• Blood Transfusion
• Hemorrhage
• Knee Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Tranexamic Acid 100 MG/ML
Tranexamic Acid: 100 MG/ML Solution for injection
• Normal saline
0.9% sodium chloride normal saline

Locations

Country	Name	City	State
Syrian Arab Republic	Damascus university	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (11)

Alshryda S, Sarda P, Sukeik M, Nargol A, Blenkinsopp J, Mason JM. Tranexamic acid in total knee replacement: a systematic review and meta-analysis. J Bone Joint Surg Br. 2011 Dec;93(12):1577-85. doi: 10.1302/0301-620X.93B12.26989. — View Citation

Benoni G, Lethagen S, Fredin H. The effect of tranexamic acid on local and plasma fibrinolysis during total knee arthroplasty. Thromb Res. 1997 Feb 1;85(3):195-206. doi: 10.1016/s0049-3848(97)00004-2. Erratum In: hromb Res 1997 Oct 15;88(2):251. — View Citation

Berman AT, Geissele AE, Bosacco SJ. Blood loss with total knee arthroplasty. Clin Orthop Relat Res. 1988 Sep;(234):137-8. — View Citation

Cankaya D, Dasar U, Satilmis AB, Basaran SH, Akkaya M, Bozkurt M. The combined use of oral and topical tranexamic acid is a safe, efficient and low-cost method in reducing blood loss and transfusion rates in total knee arthroplasty. J Orthop Surg (Hong Kong). 2017 Jan;25(1):2309499016684725. doi: 10.1177/2309499016684725. — View Citation

Charoencholvanich K, Siriwattanasakul P. Tranexamic acid reduces blood loss and blood transfusion after TKA: a prospective randomized controlled trial. Clin Orthop Relat Res. 2011 Oct;469(10):2874-80. doi: 10.1007/s11999-011-1874-2. Epub 2011 Apr 22. — View Citation

Gross JB. Estimating allowable blood loss: corrected for dilution. Anesthesiology. 1983 Mar;58(3):277-80. doi: 10.1097/00000542-198303000-00016. No abstract available. — View Citation

Lin C, Qi Y, Jie L, Li HB, Zhao XC, Qin L, Jiang XQ, Zhang ZH, Ma L. Is combined topical with intravenous tranexamic acid superior than topical, intravenous tranexamic acid alone and control groups for blood loss controlling after total knee arthroplasty: A meta-analysis. Medicine (Baltimore). 2016 Dec;95(51):e5344. doi: 10.1097/MD.0000000000005344. Erratum In: Medicine (Baltimore). 2017 Feb 17;96(7):e6208. — View Citation

Marra F, Rosso F, Bruzzone M, Bonasia DE, Dettoni F, Rossi R. Use of tranexamic acid in total knee arthroplasty. Joints. 2017 Feb 7;4(4):202-213. doi: 10.11138/jts/2016.4.4.202. eCollection 2016 Oct-Dec. — View Citation

Nielsen CS, Jans O, Orsnes T, Foss NB, Troelsen A, Husted H. Combined Intra-Articular and Intravenous Tranexamic Acid Reduces Blood Loss in Total Knee Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial. J Bone Joint Surg Am. 2016 May 18;98(10):835-41. doi: 10.2106/JBJS.15.00810. — View Citation

Roy SP, Tanki UF, Dutta A, Jain SK, Nagi ON. Efficacy of intra-articular tranexamic acid in blood loss reduction following primary unilateral total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2012 Dec;20(12):2494-501. doi: 10.1007/s00167-012-1942-5. Epub 2012 Mar 15. — View Citation

Wang H, Shen B, Zeng Y. Comparison of topical versus intravenous tranexamic acid in primary total knee arthroplasty: a meta-analysis of randomized controlled and prospective cohort trials. Knee. 2014 Dec;21(6):987-93. doi: 10.1016/j.knee.2014.09.010. Epub 2014 Oct 23. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Blood Loss(TBL)	Total Blood Loss(TBL) in the perioperative period was calculated using the Gross formula, which is estimated by hitting the patients' blood volume by the difference between pre and post-operative hematocrit value divided by the initial hematocrit value	calculated by an equation at the 72h postoperative
Primary	intra-operative blood loss	the amount of lost blood intraoperatively and will be measured by calculating the increased weight of the utilized wet mops and the volume of the suction bottle after erasing the amount of the used lavage	measured during surgery time (From the time of the surgical incision at the beginning of the operation until the time of wound closure at the end of the operation), Which equals about an hour
Primary	post-operative blood loss	the amount of lost blood postoperatively will be calculated as the output of the drain bottle	measured once 2 days after surgery
Primary	hidden blood loss	the amount of lost blood in the tissues that were not measured intraoperatively or postoperatively and will be calculated using the difference between total blood loss and intra and post-operative blood loss	measured once 3 days after surgery
Secondary	Transfusion rates	Include The number of units of perioperative blood transfusions, both intraoperative and postoperative, throughout the patient's hospital stay.	from the day of surgery to the day of discharge,an expected average of 3 days
Secondary	perioperative complication	such as infection, VTE, etc	assesed if happened within month interval untill 6 months after surgery