Postoperative BleedingTXANCT06208267
Tranexamic Acid Use on Pain, Mobility and Bleeding Following Total Hip and Total Knee Arthroplasty
A study testing Tranexamic acid in people with Postoperative Bleeding, run by St. Mary's Research Center, Canada at 1 site in Canada.
Trial summary
Tranexamic acid (TXA) is an anti-fibrinolytic agent developed in the 1960s that has been safely used to reduce blood loss, transfusion rates and bleeding-associated mortality in trauma, obstetrics and orthopedic surgery, including hip fracture care and arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Bleeding
- What is being tested?
- Tranexamic acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteCanada
- Study dates
- 20 Aug 2025to Jul 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ° All adults undergoing primary TKA and THA at St-Mary's Hospital
Who cannot join
- Age < 18 years
- Known hypersensitivity or allergy to TXA
- Previous history of thromboembolic disease
- Active malignancy (all current cancers other than local skin cancer)
- Significant renal disease (hematuria, dialysis, kidney transplant)
- History of convulsions
Show all 9Show fewer
- Known defective colour vision
- Inability or unwillingness to use MyMobility app
- Unable to communicate in French or English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
St. Mary's Hospital Center
Montreal, Quebec, H3T 1M5
Jennifer Mutch, MDCM, FRCSC, 514 345 3511 ext. 3282, j.mutch.ortho@gmail.com
Sandhya Baskaran, MBA, M.ED, 514 239 0042, sandhya.baskaran.comtl@ssss.gouv.qc.ca
About this study
Official title: The Impact of Additional Post-operative Doses of Tranexamic Acid on Pain, Mobility and Bleeding Following Total Hip and Total Knee Arthroplasty: A Randomized Controlled Trial
Tranexamic acid (TXA) is an anti-fibrinolytic agent developed in the 1960s that has been safely used to reduce blood loss, transfusion rates and bleeding-associated mortality in trauma, obstetrics and orthopedic surgery, including hip fracture care and arthroplasty.
The efficacy and safety profile of TXA has been extensively studied in numerous clinical trials and observational studies. Its wide range of applications, combined with its favourable risk-benefit ratio, has led to the incorporation of TXA into clinical guidelines and protocols worldwide.
This RCT aims to compare the current standard dosing for TXA to additional TXA doses given orally post-operatively for THA and TKA patients. The goal is to compare the following between study groups: visible bleeding on post-operative dressing, mobilization (steps, amount of time moving around), pain (visual analog scale), function (Oxford hip and knee scales) and ROM at four to six weeks.
Read the detailed description
Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are some of the most common surgical procedures performed in elderly patients, with the main indication being end-stage osteoarthritis. While these procedures can result in a significant amount of bleeding, pain and stiffness post-operatively, they have been increasingly performed as day surgeries and with reduced length of stay.
Tranexamic acid (TXA) is an anti-fibrinolytic agent developed in the 1960s that has been safely used to reduce blood loss, transfusion rates and bleeding-associated mortality in trauma, obstetrics and orthopedic surgery, including hip fracture care and arthroplasty.
The efficacy and safety profile of TXA has been extensively studied in numerous clinical trials and observational studies. Its wide range of applications, combined with its favourable risk-benefit ratio, has led to the incorporation of TXA into clinical guidelines and protocols worldwide.
The current standard of care at St-Mary's for TXA use is one gram given intravenously (IV) at the beginning of the replacement and one gram given during cementation. However, despite the established benefits of TXA, the optimal dosing regimen continues to be an area of ongoing research and discussion.
TXA and post-operative hemoglobin and hematocrit levels The use of TXA in knee and hip arthroplasty has been shown to have clear and significant benefits in reducing the post-operative drop in hemoglobin (Hb) and hematocrit (Hct) but the duration of use has ranged from a single pre-operative dose to a prolonged 14-day course. Researchers reported higher post-operative Hb and Hct following THA and TKA using a three-day course of TXA compared to a single pre-operative dose of 1.5g. However another study, showed no added benefit of the addition of a second post-operative dose to the single pre-operative dose. Similarly, an randomized controlled trial (RCT) comparing TXA doses at pre, during and three hours post-operative to the same with additional doses at six and 12 hours and showed no added benefit of the additional two doses on Hb or Hct levels. In contrast to this, three RCTs performed in 2019 and 2021 showed improved Hb and Hct levels with TXA use beyond a minimum of seven hours post-operatively and two involved the use of TXA given by mouth (PO), which is ideal in the ambulatory setting.
TXA and Ambulation/Motion The majority of the studies involving varying doses of TXA following THA and TKA have not assessed articular motion nor ambulation post-operatively. These can have an impact on patient satisfaction as well as the ability to mobilize and be able to leave the hospital earlier. TXA was compared to placebo and demonstrated that patients who received TXA ambulated 20% more during physiotherapy sessions. Several TXA regimens with patients receiving a minimum of three post-operative doses (maximum of four post-operative doses were studied),showed having significantly better range of motion (ROM) than patients who received less. Additionally, these patients reported less post-operative pain.
TXA and Complications
No increase in adverse events were reported in any of these studies following prolonged TXA use. Cardiovascular events, deep vein thrombosis (DVT), pulmonary embolism (PE), renal failure or superficial thrombosis were not different among study groups in the rare cases where they occurred, even with oral TXA given for up to 14 days post-operatively
. At St-Mary's Hospital, we perform a large number of TKAs and THAs, around 1100 per year (600 knees, 500 hips), making us the most productive hospital performing these procedures in Québec. Also, partly driven by the constraints of the pandemic over the past three years, we have successfully and safely reduced the length of stay for our patients and converted hundreds of patients to day surgery. Bleeding, however, remains a significant source of patient anxiety, with 10% of our ambulatory cases needing additional CLSC care or even return to hospital. Rapid mobilization and decrease in post- operative pain are also key factors for a rapid and safe discharge from hospital.
In this RCT, we aim to compare our current standard dosing for TXA to additional TXA doses given orally post-operatively for our THA and TKA patients. We will be the first of this type of study to assess patient mobility using a wearable device that will allow for precise measurement of step counts, amount of time moving around and sleep times. Also new compared to previous studies, will be our assessment of bleeding complications requiring intervention and needs for additional hospital or nursing visits, both of which have and impact on the cost of care. Pain (VAS scale), function (Oxford hip and knee scales) and ROM will also be assessed at 4-6 weeks.
- Conditions
- Postoperative Bleeding
- Being tested
- Tranexamic acid
- Medical subject headings
- Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called CYKLOKAPRON
This is a 3 arm RCT using the three dosage regimens mentioned above. Placebo doses will be provided for the 0, 8, 16 and 24 hours without TXA
| Study group | Role | What they receive |
|---|---|---|
| 1)Standard care: 1G TXA IV | Active comparator | 1 gm TA IV given prior to incision and 1G TXA IV during cementation or closure Receives: Drug: Tranexamic acid |
| 2) Standard + 1G oral TXA - 0 and 8 hours post-operatively | Active comparator | Standard + 1G oral TXA given at 0 and 8 hours post-operatively Receives: Drug: Tranexamic acid |
| 3) Standard + 1G oral TXA given at 0, 8, 16 and 24 hours post-operatively | Active comparator | Standard + 1G oral TXA given at 0, 8, 16 and 24 hours post-operatively Receives: Drug: Tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step counts at 24 and 48 hours post -operative
We hypothesize that patients receiving additional doses of TXA will mobilize more at 24 and 48 hours post- operatively and that this will be dose-dependent.
Measured: Post-operative
Secondary outcomes (11)
Range of motion (ROM) of the hip (if applicable):
Measuring ROM of the hip taken pre-operatively, post-operatively and 4 to 6 weeks post-operatively if patient received a total hip arthroplasty (THA)
Measured: 4 - 6 weeks post op
Range of motion (ROM) of the knee (if applicable):
Measuring ROM of the knee taken pre-operatively, post-operatively and 4 to 6 weeks post-operatively if patient received a total knee arthroplasty (TKA).
Measured: 4 - 6 weeks post op
Patient self-assessment of functionality and pain measured pre-operatively, 4 to 6 weeks postoperatively, 3 months postoperatively and 6 months post-operatively following total hip arthroplasty utilizing the Oxford Hip Score (OHS):
Minimal value of 0 and maximal value of 48. The higher scores indicate more satisfactory joint function.
Measured: 4 to 6 weeks postoperatively, 3 months postoperatively and 6 months post-operatively
Patient self-assessment of functionality and pain measured pre-operatively, 4 to 6 weeks postoperatively, 3 months postoperatively and 6 months post-operatively following total knee arthroplasty utilizing the Oxford Knee Score (OKS):
joint function.
Measured: 4 to 6 weeks postoperatively, 3 months postoperatively and 6 months post-operatively
Bleeding Complications requiring intervention
Bleeding that require a specific intervntion from CLSC/Clinic/Hospital visits
Measured: Return to the emergency room or bleeding complications will be noted.
Daily step counts
To be measured with an application (MyMobility) on a smartphone or smartwatch used by the patient. This is a numerical value simply describing the number of steps taken by the patient on a day-to-day basis. This measurement will be collected pre-operatively (until OR), on post-operative day 0,1,2,3,5,7 and 4 to 6 weeks postoperatively.
Measured: Post-operative day 0,1,2,3,5,7 and 4 to 6 weeks postoperatively.
Measure of quality of life using the 12-Item Short Form Survey (SF-12):
Regarding minimum and maximum values, there are two summary scores that are reported from the SF-12: there is a mental component score (MCS-12) and a physical component score (PCS-12). The scores may also be reported as Z-scores where a difference would be compared to the population average.
In the literature, SF-12 results have also been computed as a range going from a minimum value of 0 to a maximum value of 100, where higher scores indicate better physical and mental health functioning.
Measured: This measurement will be taken pre-operatively, 4 to 6 weeks postoperatively, 3 months postoperatively and 6 months post-operatively.
Assessment and screening for depression and anxiety in patients utilizing the Hospital Anxiety Depression Scale (HADS) :
Minimum score of 0 and maximum score of 21. The higher scores indicate higher distress.
Measured: Pre-operative
Reported pain self-reported in patient journal and possibly in-patient charts:
This is a numerical value. Patient journals and/or in-patient charts, if applicable, would be screened for frequency of opioid use as a way of evaluating pain management post-operatively.
Measured: These journals and/or in-patient charts will be verified on postoperative day 0,1,2,3,5 and 7.
Assessment of catastrophic thinking related to pain utilizing the Pain Catastrophizing Scale (PCS):
Minimum score of 0 and maximum score of 52. The higher scores indicate higher levels of catastrophizing.
Measured: Pre-operative
Reported pain using the visual analog pain (VAS) scale:
The pain VAS scale involves a numerical rating scale or a descriptive rating scale that progressively goes from a minimal value indicating severe pain to a maximal value indicating good pain management.
Measured: This measurement will be collected on postoperative day 0, 1,2,3,5 and 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start20 Aug 2025
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative BleedingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Mary's Research Center, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Albers, MD, St. Mary's Research Center, Canada
- Investigators
- Jennifer Mutch, MDCM, FRCSC, Principal investigator, St. Mary's Hospital Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208267
- Sponsor's protocol ID
- 2024-1082
- Acronym
- TXA
- Status last verified
- Apr 2026
- First submitted
- 2 Nov 2023
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Additional Post-operative Doses of Tranexamic Acid on Pain, Mobility and Bleeding Following Total Hip and Total Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06208267
- Acronym / sponsor ID
- TXA / 2024-1082
- Conditions
- Postoperative Bleeding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- St. Mary's Research Center, CanadaUniversity, hospital or other
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Jan 2024 (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.
Tranexamic acid (TXA) is an anti-fibrinolytic agent developed in the 1960s that has been safely used to reduce blood loss, transfusion rates and bleeding-associated mortality in trauma, obstetrics and orthopedic surgery, including hip fracture care and arthroplasty.
The efficacy and safety profile of TXA has been extensively studied in numerous clinical trials and observational studies. Its wide range of applications, combined with its favourable risk-benefit ratio, has led to the incorporation of TXA into clinical guidelines and protocols worldwide.
This RCT aims to compare the current standard dosing for TXA to additional TXA doses given orally post-operatively for THA and TKA patients. The goal is to compare the following between study groups: visible bleeding on post-operative dressing, mobilization (steps, amount of time moving around), pain (visual analog scale), function (Oxford hip and knee scales) and ROM at four to six weeks.
Detailed description
Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are some of the most common surgical procedures performed in elderly patients, with the main indication being end-stage osteoarthritis. While these procedures can result in a significant amount of bleeding, pain and stiffness post-operatively, they have been increasingly performed as day surgeries and with reduced length of stay.
Tranexamic acid (TXA) is an anti-fibrinolytic agent developed in the 1960s that has been safely used to reduce blood loss, transfusion rates and bleeding-associated mortality in trauma, obstetrics and orthopedic surgery, including hip fracture care and arthroplasty.
The efficacy and safety profile of TXA has been extensively studied in numerous clinical trials and observational studies. Its wide range of applications, combined with its favourable risk-benefit ratio, has led to the incorporation of TXA into clinical guidelines and protocols worldwide.
The current standard of care at St-Mary's for TXA use is one gram given intravenously (IV) at the beginning of the replacement and one gram given during cementation. However, despite the established benefits of TXA, the optimal dosing regimen continues to be an area of ongoing research and discussion.
TXA and post-operative hemoglobin and hematocrit levels The use of TXA in knee and hip arthroplasty has been shown to have clear and significant benefits in reducing the post-operative drop in hemoglobin (Hb) and hematocrit (Hct) but the duration of use has ranged from a single pre-operative dose to a prolonged 14-day course. Researchers reported higher post-operative Hb and Hct following THA and TKA using a three-day course of TXA compared to a single pre-operative dose of 1.5g. However another study, showed no added benefit of the addition of a second post-operative dose to the single pre-operative dose. Similarly, an randomized controlled trial (RCT) comparing TXA doses at pre, during and three hours post-operative to the same with additional doses at six and 12 hours and showed no added benefit of the additional two doses on Hb or Hct levels. In contrast to this, three RCTs performed in 2019 and 2021 showed improved Hb and Hct levels with TXA use beyond a minimum of seven hours post-operatively and two involved the use of TXA given by mouth (PO), which is ideal in the ambulatory setting.
TXA and Ambulation/Motion The majority of the studies involving varying doses of TXA following THA and TKA have not assessed articular motion nor ambulation post-operatively. These can have an impact on patient satisfaction as well as the ability to mobilize and be able to leave the hospital earlier. TXA was compared to placebo and demonstrated that patients who received TXA ambulated 20% more during physiotherapy sessions. Several TXA regimens with patients receiving a minimum of three post-operative doses (maximum of four post-operative doses were studied),showed having significantly better range of motion (ROM) than patients who received less. Additionally, these patients reported less post-operative pain.
TXA and Complications
No increase in adverse events were reported in any of these studies following prolonged TXA use. Cardiovascular events, deep vein thrombosis (DVT), pulmonary embolism (PE), renal failure or superficial thrombosis were not different among study groups in the rare cases where they occurred, even with oral TXA given for up to 14 days post-operatively
. At St-Mary's Hospital, we perform a large number of TKAs and THAs, around 1100 per year (600 knees, 500 hips), making us the most productive hospital performing these procedures in Québec. Also, partly driven by the constraints of the pandemic over the past three years, we have successfully and safely reduced the length of stay for our patients and converted hundreds of patients to day surgery. Bleeding, however, remains a significant source of patient anxiety, with 10% of our ambulatory cases needing additional CLSC care or even return to hospital. Rapid mobilization and decrease in post- operative pain are also key factors for a rapid and safe discharge from hospital.
In this RCT, we aim to compare our current standard dosing for TXA to additional TXA doses given orally post-operatively for our THA and TKA patients. We will be the first of this type of study to assess patient mobility using a wearable device that will allow for precise measurement of step counts, amount of time moving around and sleep times. Also new compared to previous studies, will be our assessment of bleeding complications requiring intervention and needs for additional hospital or nursing visits, both of which have and impact on the cost of care. Pain (VAS scale), function (Oxford hip and knee scales) and ROM will also be assessed at 4-6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1)Standard care: 1G TXA IV | Active comparator | Drug: Tranexamic acid1 gm TA IV given prior to incision and 1G TXA IV during cementation or closure |
| 2) Standard + 1G oral TXA - 0 and 8 hours post-operatively | Active comparator | Drug: Tranexamic acidStandard + 1G oral TXA given at 0 and 8 hours post-operatively |
| 3) Standard + 1G oral TXA given at 0, 8, 16 and 24 hours post-operatively | Active comparator | Drug: Tranexamic acidStandard + 1G oral TXA given at 0, 8, 16 and 24 hours post-operatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ° All adults undergoing primary TKA and THA at St-Mary's Hospital
Key exclusion criteria (9 listed)
- Age < 18 years
- Known hypersensitivity or allergy to TXA
- Previous history of thromboembolic disease
- Active malignancy (all current cancers other than local skin cancer)
- Significant renal disease (hematuria, dialysis, kidney transplant)
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 acidAlso: CYKLOKAPRONThis is a 3 arm RCT using the three dosage regimens mentioned above. Placebo doses will be provided for the 0, 8, 16 and 24 hours without TXA | Drug | 1)Standard care: 1G TXA IV, 2) Standard + 1G oral TXA - 0 and 8 hours post-operatively, 3) Standard + 1G oral TXA given at 0, 8, 16 and 24 hours post-operatively |
Primary outcome
Step counts at 24 and 48 hours post -operative
Time frame: Post-operative
We hypothesize that patients receiving additional doses of TXA will mobilize more at 24 and 48 hours post- operatively and that this will be dose-dependent.
11 secondary outcomes
Range of motion (ROM) of the hip (if applicable):
Time frame: 4 - 6 weeks post op
Range of motion (ROM) of the knee (if applicable):
Time frame: 4 - 6 weeks post op
Patient self-assessment of functionality and pain measured pre-operatively, 4 to 6 weeks postoperatively, 3 months postoperatively and 6 months post-operatively following total hip arthroplasty utilizing the Oxford Hip Score (OHS):
Time frame: 4 to 6 weeks postoperatively, 3 months postoperatively and 6 months post-operatively
Patient self-assessment of functionality and pain measured pre-operatively, 4 to 6 weeks postoperatively, 3 months postoperatively and 6 months post-operatively following total knee arthroplasty utilizing the Oxford Knee Score (OKS):
Time frame: 4 to 6 weeks postoperatively, 3 months postoperatively and 6 months post-operatively
Bleeding Complications requiring intervention
Time frame: Return to the emergency room or bleeding complications will be noted.
Daily step counts
Time frame: Post-operative day 0,1,2,3,5,7 and 4 to 6 weeks postoperatively.
Measure of quality of life using the 12-Item Short Form Survey (SF-12):
Time frame: This measurement will be taken pre-operatively, 4 to 6 weeks postoperatively, 3 months postoperatively and 6 months post-operatively.
Assessment and screening for depression and anxiety in patients utilizing the Hospital Anxiety Depression Scale (HADS) :
Time frame: Pre-operative
Reported pain self-reported in patient journal and possibly in-patient charts:
Time frame: These journals and/or in-patient charts will be verified on postoperative day 0,1,2,3,5 and 7.
Assessment of catastrophic thinking related to pain utilizing the Pain Catastrophizing Scale (PCS):
Time frame: Pre-operative
Reported pain using the visual analog pain (VAS) scale:
Time frame: This measurement will be collected on postoperative day 0, 1,2,3,5 and 7.
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 28 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Jennifer Mutch, MDCM, FRCSC principal investigator
St. Mary's Hospital Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid in people with Postoperative Bleeding, run by St. Mary's Research Center, Canada at 1 site in Canada.
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 1 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 28 Apr 2026. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Jennifer Mutch, MDCM, FRCSC (514 345 3511 ext. 3282, j.mutch.ortho@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step counts at 24 and 48 hours post -operative (time frame: Post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2026.