Use of Tranexamic Acid in the Total Knee Arthroplasty.

NCT05919615 | Completed

• 1 other identifier: UDMS-Orthopedics-4-2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis; Blood Loss; Blood Transfusion

Keywords

tranexamic acid; total knee arthroplasty; blood loss; complication

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (2)

• Transfusion rates

  from the day of surgery to the day of discharge,an expected average of 3 days

• perioperative complication

  assesed if happened within month interval untill 6 months after surgery

Study Arms (2)

intravenous tranexamic acid

EXPERIMENTAL

The intervention group comprised patients 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.

Drug: Tranexamic Acid 100 MG/ML

placebo

PLACEBO COMPARATOR

The control group comprised primary unilateral TKA patients who did not use TXA, just IV normal saline (0.9% sodium chloride).

Drug: Normal saline

Interventions

Tranexamic Acid 100 MG/ML DRUG

Tranexamic Acid: 100 MG/ML Solution for injection

Also known as: TXA

intravenous tranexamic acid

Normal saline DRUG

0.9% sodium chloride normal saline

Also known as: NS

placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with primary knee osteoarthrosis who underwent unilateral primary TKA

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus university

Damascus, Syria

Location

Related 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.

  PMID: 22161917 BACKGROUND

• 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.

  PMID: 25450009 BACKGROUND

• 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.

  PMID: 28002321 BACKGROUND

• 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.

  PMID: 28176599 BACKGROUND

• 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.

  PMID: 9058494 BACKGROUND

• 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.

  PMID: 21512813 BACKGROUND

• 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.

  PMID: 27194493 BACKGROUND

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

  PMID: 3409568 BACKGROUND

• 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.

  PMID: 6829965 BACKGROUND

• 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.

  PMID: 28217656 BACKGROUND

• 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.

  PMID: 22419263 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Hemorrhage

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jaber Ibrahim, M.D, Ph.D

  Damascus University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: triple Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: June 26, 2023
• Study Start: July 15, 2021
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)