Extended Postoperative Oral Tranexamic Acid in Knee Replacement
NCT ID: NCT05099276
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
46 participants
INTERVENTIONAL
2021-12-07
2024-06-01
Brief Summary
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Detailed Description
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Following written consent documentation, Subjects will be randomized and blinded to randomization assignment until completion of study to either the oral TXA group or oral placebo group. The study medication will be distributed with the Subject's name with instructions for use in the post-anesthesia unit (PACU). The first dose will be administered in PACU with subsequent doses to be taken at home on postop day one and postop day two. TKA will be completed in an ambulatory surgery center with discharge same day of surgery to home.
Outcome measures include: Hemoglobin, visual analog score, KOOS Jr (Knee injury and osteoarthritis outcome score), range of motion, and incidence of treatment-emergent adverse event at postoperative (POD) day 3, POD week 2, POD week 6, and POD week 12. KOOS Jr. will be collected at one year post-op.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Oral TXA
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.
Tranexamic Acid Pill
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 placebo
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.
Placebo
Three capsules of cellulose given in post-anesthesia room and three capsules for postop cay one and three capsules for postop day two
Interventions
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Tranexamic Acid Pill
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
Placebo
Three capsules of cellulose given in post-anesthesia room and three capsules for postop cay one and three capsules for postop day two
Eligibility Criteria
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Inclusion Criteria
* Willing to participate
* Physical therapy on site at Campbell Clinic Wolf River
* Fluent in oral and written English
Exclusion Criteria
* 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
18 Years
80 Years
ALL
Yes
Sponsors
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Campbell Clinic
OTHER
Responsible Party
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Marcus C. Ford
Research Manager
Principal Investigators
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Marcus C Ford, MD
Role: PRINCIPAL_INVESTIGATOR
Campbell Clinic
Locations
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Campbell Clinic
Germantown, Tennessee, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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21-08313-FB
Identifier Type: -
Identifier Source: org_study_id
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