Knee OsteoarthritisPhase 4NCT05099276
Extended Postoperative Oral Tranexamic Acid in Knee Replacement
A Phase 4 study testing Tranexamic Acid Pill in people with Knee Osteoarthritis and Blood Loss, run by Campbell Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis, Blood Loss, Pain, Postoperative
- What is being tested?
- Tranexamic Acid Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2021to 1 Jun 2024
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extended Postoperative Tranexamic Acid Use in Primary Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial
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.
Read the detailed description
Significant blood loss occurs during total knee arthroplasty (TKA) which can lead to adverse outcomes including need for blood transfusion as well as increased local tissue swelling and ecchymosis which can inhibit post-operative recovery. Tranexamic acid (TXA), an inhibitor of fibrinolysis, has been shown to be a safe and effective drug for reducing blood loss during and after TKA. The use of TXA intraoperatively has been associated with higher postoperative hemoglobin levels and a reduction in postoperative blood transfusion rates. Administration of TXA in TKA has also been associated with improved clinical outcome measures including decreased rate of periprosthetic joint infection, decreased length of stay, and increased postoperative range of motion and early ambulation distances. However, there remains a wide variance in the route of administration, dosage, and timing of TXA use among treatment protocols in TKA. Previous studies have evaluated outcomes with the addition of post-operative TXA dosing to standard pre-operative and intra-operative intravenous (IV) doses. This study will investigate patient outcomes following a standardized post-operative oral TXA protocol as compared to oral placebo for three doses over day of surgery, postop day one and postop day two after TKA.
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
- Knee Osteoarthritis, Blood Loss, Pain, Postoperative
- Being tested
- Tranexamic Acid Pill, Placebo
- Medical subject headings
- Osteoarthritis, Knee, Hemorrhage, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid PillDrug
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
PlaceboDrug
Three capsules of cellulose given in post-anesthesia room and three capsules for postop cay one and three capsules for postop day two
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: postoperative week 2
Secondary outcomes (16)
Visual Analog Score
Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain
Measured: preoperative
Visual Analog Score
Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain
Measured: postoperative hour 3
Visual Analog Score
Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain
Measured: postoperative week 2
Visual Analog Score
Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain
Measured: postoperative week 6
Visual Analog Score
Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain
Measured: postoperative week 12
KOOS Jr Score
Patient reported outcome of how the knee feels from 0 to one 100 where 0 represents extreme problems and 100 represents no problems
Measured: preoperative
KOOS Jr Score
Patient reported outcome of how the knee feels from 0 to one 100 where 0 represents extreme problems and 100 represents no problems
Measured: postoperative day 3
KOOS Jr Score
Patient reported outcome of how the knee feels from 0 to one 100 where 0 represents extreme problems and 100 represents no problems
Measured: postoperative week 2
KOOS Jr Score
Patient reported outcome of how the knee feels from 0 to one 100 where 0 represents extreme problems and 100 represents no problems
Measured: postoperative week 6
KOOS Jr Score
Patient reported outcome of how the knee feels from 0 to one 100 where 0 represents extreme problems and 100 represents no problems
Measured: postoperative week 12
KOOS Jr Score
Patient reported outcome of how the knee feels from 0 to one 100 where 0 represents extreme problems and 100 represents no problems
Measured: postoperative one year
range of motion of knee
clinical measurement of passive, pain-free range of motion of knee in degrees from 0 to 180 from maximum extension to maximum flexion
Measured: preoperative
range of motion of knee
clinical measurement of passive, pain-free range of motion of knee in degrees from 0 to 180 from maximum extension to maximum flexion
Measured: postoperative day 3
range of motion of knee
clinical measurement of passive, pain-free range of motion of knee in degrees from 0 to 180 from maximum extension to maximum flexion
Measured: postoperative week 2
range of motion of knee
clinical measurement of passive, pain-free range of motion of knee in degrees from 0 to 180 from maximum extension to maximum flexion
Measured: postoperative week 6
range of motion of knee
clinical measurement of passive, pain-free range of motion of knee in degrees from 0 to 180 from maximum extension to maximum flexion
Measured: postoperative week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start7 Dec 2021
- Primary completion31 Dec 2023
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campbell Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcus C. Ford, Campbell Clinic
- Investigators
- Marcus C Ford, MD, Principal investigator, Campbell Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099276
- Sponsor's protocol ID
- 21-08313-FB
- Status last verified
- Mar 2024
- First submitted
- 11 Oct 2021
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29699826Rutherford 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.
PubMed 28870300Prasad 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.
PubMed 16568327Kim 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.
PubMed 32869124Wu 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.
PubMed 32862267Drain 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.
PubMed 32209286Grosso 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.
PubMed 29560399Torkaman 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.
PubMed 32766393Lei 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.
PubMed 32253548Pavenski 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.
PubMed 30383292Luo 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.
PubMed 29107495Wang 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.
PubMed 31653221Wang 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.
PubMed 30062946Kirwan MJ, Diltz ZR, Dixon DT, Rivera-Peraza CA, Gammage CJ, Mihalko WM, Harkess JW, Guyton JL, Crockarell JR, Ford MC. The AAHKS Clinical Research Award: Extended Postoperative Oral Tranexamic Acid in Total Knee Arthroplasty: A Randomized Controlled Pilot Study. J Arthroplasty. 2024 Sep;39(9 Suppl 2):S13-S17. doi: 10.1016/j.arth.2024.02.073. Epub 2024 Feb 29.
PubMed 38430972
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Postoperative Tranexamic Acid Use in Primary Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05099276
- Acronym / sponsor ID
- 21-08313-FB
- Conditions
- Knee Osteoarthritis, Blood Loss, Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Campbell ClinicUniversity, hospital or other
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Significant blood loss occurs during total knee arthroplasty (TKA) which can lead to adverse outcomes including need for blood transfusion as well as increased local tissue swelling and ecchymosis which can inhibit post-operative recovery. Tranexamic acid (TXA), an inhibitor of fibrinolysis, has been shown to be a safe and effective drug for reducing blood loss during and after TKA. The use of TXA intraoperatively has been associated with higher postoperative hemoglobin levels and a reduction in postoperative blood transfusion rates. Administration of TXA in TKA has also been associated with improved clinical outcome measures including decreased rate of periprosthetic joint infection, decreased length of stay, and increased postoperative range of motion and early ambulation distances. However, there remains a wide variance in the route of administration, dosage, and timing of TXA use among treatment protocols in TKA. Previous studies have evaluated outcomes with the addition of post-operative TXA dosing to standard pre-operative and intra-operative intravenous (IV) doses. This study will investigate patient outcomes following a standardized post-operative oral TXA protocol as compared to oral placebo for three doses over day of surgery, postop day one and postop day two after TKA.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral TXA | Experimental | Drug: Tranexamic Acid Pill1,950 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. |
| Oral placebo | Placebo comparator | Drug: PlaceboThree 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid Pill1950 mg tranexamic acid (three capsules) given in post-anesthesia room and three capsules for postop day one and three capsules for postop day two | Drug | Oral TXA |
| PlaceboThree capsules of cellulose given in post-anesthesia room and three capsules for postop cay one and three capsules for postop day two | Drug | Oral placebo |
Primary outcome
Hemoglobin level
Time frame: preoperative
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
Hemoglobin level
Time frame: postoperative hour 3
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
Hemoglobin level
Time frame: postoperative day 3
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
Hemoglobin level
Time frame: postoperative week 2
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
16 secondary outcomes
Visual Analog Score
Time frame: preoperative
Visual Analog Score
Time frame: postoperative hour 3
Visual Analog Score
Time frame: postoperative week 2
Visual Analog Score
Time frame: postoperative week 6
Visual Analog Score
Time frame: postoperative week 12
KOOS Jr Score
Time frame: preoperative
KOOS Jr Score
Time frame: postoperative day 3
KOOS Jr Score
Time frame: postoperative week 2
KOOS Jr Score
Time frame: postoperative week 6
KOOS Jr Score
Time frame: postoperative week 12
KOOS Jr Score
Time frame: postoperative one year
range of motion of knee
Time frame: preoperative
range of motion of knee
Time frame: postoperative day 3
range of motion of knee
Time frame: postoperative week 2
range of motion of knee
Time frame: postoperative week 6
range of motion of knee
Time frame: postoperative week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Background: PubMed 29699826Fillingham 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.
- Results publication: PubMed 28870300Rutherford 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.
- Results publication: PubMed 16568327Prasad 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.
- Results publication: PubMed 32869124Kim 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.
- Results publication: PubMed 32862267Wu 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.
- Results publication: PubMed 32209286Drain 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.
- Results publication: PubMed 29560399Grosso 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.
- Results publication: PubMed 32766393Torkaman 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.
- Results publication: PubMed 32253548Lei 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.
- Results publication: PubMed 30383292Pavenski 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.
- Results publication: PubMed 29107495Luo 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.
- Results publication: PubMed 31653221Wang 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.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus C Ford, MD principal investigator
Campbell Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid Pill in people with Knee Osteoarthritis and Blood Loss, run by Campbell Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin level (time frame: preoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05099276, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.