Extended Postoperative Oral Tranexamic Acid in Knee Replacement

NCT05099276 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 21-08313-FB
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

A comparison of outcomes between use of oral tranexamic acid as compared to oral placebo in the first days after total knee replacement will be made to determine impact on clinical indications and patient reported outcomes.

Conditions

Knee Osteoarthritis; Blood Loss; Pain, Postoperative

Outcome Measures

Primary Outcomes (4)

• Hemoglobin level

  Hemoglobin enables red cells to transport oxygen and carbon dioxide in the blood and is measured in grams per deciliter with normal ranges of 12.0 to 17.5

  preoperative

• Hemoglobin level

  Hemoglobin enables red cells to transport oxygen and carbon dioxide in the blood and is measured in grams per deciliter with normal ranges of 12.0 to 17.5

  postoperative hour 3

• Hemoglobin level

  Hemoglobin enables red cells to transport oxygen and carbon dioxide in the blood and is measured in grams per deciliter with normal ranges of 12.0 to 17.5

  postoperative day 3

• Hemoglobin level

  Hemoglobin enables red cells to transport oxygen and carbon dioxide in the blood and is measured in grams per deciliter with normal ranges of 12.0 to 17.5

  postoperative week 2

Secondary Outcomes (16)

• Visual Analog Score

  preoperative

• Visual Analog Score

  postoperative hour 3

• Visual Analog Score

  postoperative week 2

• Visual Analog Score

  postoperative week 6

• Visual Analog Score

  postoperative week 12

Other Outcomes (4)

• Incidence of treatment-emergent adverse event

  postoperative day 3

• Incidence of treatment-emergent adverse event

  postoperative week 2

• Incidence of treatment-emergent adverse event

  postoperative week 6

Study Arms (2)

Oral TXA

EXPERIMENTAL

1,950 mg oral tranexmic acid (three capsules of 650 mg) administered in post-anesthesia care, postop day one and postop day two. Compounded by registered pharmacist and labeled with subject name and instructions for use.

Drug: Tranexamic Acid Pill

Oral placebo

PLACEBO COMPARATOR

Three capsules of cellulose administered in post-anesthesia care, postop day one and postop day two. Compounded by registered pharmacist and labeled with subject name and instructions for use.

Drug: Placebo

Interventions

Tranexamic Acid Pill DRUG

1950 mg tranexamic acid (three capsules) given in post-anesthesia room and three capsules for postop day one and three capsules for postop day two

Oral TXA

Placebo DRUG

Three capsules of cellulose given in post-anesthesia room and three capsules for postop cay one and three capsules for postop day two

Oral placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary total knee replacement in ambulatory setting
• Willing to participate
• Physical therapy on site at Campbell Clinic Wolf River
• Fluent in oral and written English

You may not qualify if:

• Unwilling to participate
• Revision total knee replacement
• Preoperative use of anticoagulants other than 81 mg aspirin
• Previous history of thromboembolic event
• Previous history of cancer other than non-melanoma skin cancers

Sponsors & Collaborators

• Campbell Clinic: lead

Study Sites (1)

Campbell Clinic

Germantown, Tennessee, 38138, United States

Location

Related Publications (13)

• Fillingham YA, Ramkumar DB, Jevsevar DS, Yates AJ, Shores P, Mullen K, Bini SA, Clarke HD, Schemitsch E, Johnson RL, Memtsoudis SG, Sayeed SA, Sah AP, Della Valle CJ. The Safety of Tranexamic Acid in Total Joint Arthroplasty: A Direct Meta-Analysis. J Arthroplasty. 2018 Oct;33(10):3070-3082.e1. doi: 10.1016/j.arth.2018.03.031. Epub 2018 Mar 22.

  PMID: 29699826 BACKGROUND

• Rutherford RW, Jennings JM, Dennis DA. Enhancing Recovery After Total Knee Arthroplasty. Orthop Clin North Am. 2017 Oct;48(4):391-400. doi: 10.1016/j.ocl.2017.05.002. Epub 2017 Aug 8.

  PMID: 28870300 RESULT

• Prasad N, Padmanabhan V, Mullaji A. Blood loss in total knee arthroplasty: an analysis of risk factors. Int Orthop. 2007 Feb;31(1):39-44. doi: 10.1007/s00264-006-0096-9. Epub 2006 Mar 28.

  PMID: 16568327 RESULT

• Kim JK, Park JY, Lee DY, Ro DH, Han HS, Lee MC. Optimal dose of topical tranexamic acid considering efficacy and safety in total knee arthroplasty: a randomized controlled study. Knee Surg Sports Traumatol Arthrosc. 2021 Oct;29(10):3409-3417. doi: 10.1007/s00167-020-06241-9. Epub 2020 Aug 31.

  PMID: 32869124 RESULT

• Wu C, Tan C, Wang L. Higher doses of topical tranexamic acid safely improves immediate functional outcomes and reduces transfusion requirement in total knee arthroplasty. Arch Orthop Trauma Surg. 2020 Dec;140(12):2071-2075. doi: 10.1007/s00402-020-03591-4. Epub 2020 Aug 29.

  PMID: 32862267 RESULT

• Drain NP, Gobao VC, Bertolini DM, Smith C, Shah NB, Rothenberger SD, Dombrowski ME, O'Malley MJ, Klatt BA, Hamlin BR, Urish KL. Administration of Tranexamic Acid Improves Long-Term Outcomes in Total Knee Arthroplasty. J Arthroplasty. 2020 Jun;35(6S):S201-S206. doi: 10.1016/j.arth.2020.02.047. Epub 2020 Mar 4.

  PMID: 32209286 RESULT

• Grosso MJ, Trofa DP, Danoff JR, Hickernell TR, Murtaugh T, Lakra A, Geller JA. Tranexamic acid increases early perioperative functional outcomes after total knee arthroplasty. Arthroplast Today. 2017 Jun 29;4(1):74-77. doi: 10.1016/j.artd.2017.05.009. eCollection 2018 Mar.

  PMID: 29560399 RESULT

• Torkaman A, Rostami A, Sarshar MR, Akbari Aghdam H, Motaghi P, Yazdi H. The Efficacy of Intravenous Versus Topical Use of Tranexamic Acid in Reducing Blood Loss after Primary Total Knee Arthroplasty: A Randomized Clinical Trial. Arch Bone Jt Surg. 2020 May;8(3):363-367. doi: 10.22038/abjs.2020.40528.2099.

  PMID: 32766393 RESULT

• Lei Y, Xie J, Huang Q, Huang W, Pei F. Additional benefits of multiple-dose tranexamic acid to anti-fibrinolysis and anti-inflammation in total knee arthroplasty: a randomized controlled trial. Arch Orthop Trauma Surg. 2020 Aug;140(8):1087-1095. doi: 10.1007/s00402-020-03442-2. Epub 2020 Apr 6.

  PMID: 32253548 RESULT

• Pavenski K, Ward SE, Hare GMT, Freedman J, Pulendrarajah R, Pirani RA, Sheppard N, Vance C, White A, Lo N, Waddell JP, Ho A, Schemitsch EH, Kataoka M, Bogoch ER, Saini K, David Mazer C, Baker JE. A rationale for universal tranexamic acid in major joint arthroplasty: overall efficacy and impact of risk factors for transfusion. Transfusion. 2019 Jan;59(1):207-216. doi: 10.1111/trf.14995. Epub 2018 Nov 1.

  PMID: 30383292 RESULT

• Luo ZY, Wang HY, Wang D, Zhou K, Pei FX, Zhou ZK. Oral vs Intravenous vs Topical Tranexamic Acid in Primary Hip Arthroplasty: A Prospective, Randomized, Double-Blind, Controlled Study. J Arthroplasty. 2018 Mar;33(3):786-793. doi: 10.1016/j.arth.2017.09.062. Epub 2017 Oct 6.

  PMID: 29107495 RESULT

• Wang HY, Wang L, Luo ZY, Wang D, Tang X, Zhou ZK, Pei FX. Intravenous and subsequent long-term oral tranexamic acid in enhanced-recovery primary total knee arthroplasty without the application of a tourniquet: a randomized placebo-controlled trial. BMC Musculoskelet Disord. 2019 Oct 25;20(1):478. doi: 10.1186/s12891-019-2885-5.

  PMID: 31653221 RESULT

• Wang D, Wang HY, Luo ZY, Meng WK, Pei FX, Li Q, Zhou ZK, Zeng WN. Blood-conserving efficacy of multiple doses of oral tranexamic acid associated with an enhanced-recovery programme in primary total knee arthroplasty: a randomized controlled trial. Bone Joint J. 2018 Aug;100-B(8):1025-1032. doi: 10.1302/0301-620X.100B8.BJJ-2017-1598.R1.

  PMID: 30062946 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Hemorrhage; Pain, Postoperative

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Marcus C Ford, MD

  Campbell Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Both oral TXA and oral placebo will be distributed to subjects in bottle marked with subject name and instructions for use following discharge from PACU.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 29, 2021
• Study Start: December 7, 2021
• Primary Completion: December 31, 2023
• Study Completion: June 1, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)