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Comparing 3 approaches for postoperative bleeding

Official title: Tranexamic Acid Use on Pain, Mobility and Bleeding Following Total Hip and Total Knee Arthroplasty

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

Condition: Postoperative BleedingSponsor: St. Mary's Research Center, CanadaTarget enrollment: 210
  • 3 groups
  • One site, in Montreal
  • Recruiting
St. Mary's Hospital Center, Montreal, Quebec

Interventions

  • Medication

    Tranexamic acid

    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

Canadian Sites (1)

1 of 1 recruiting

  • St. Mary's Hospital Center

    Montreal, Quebec

    Recruiting

Eligibility Criteria

See who this study is looking for10 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +° All adults undergoing primary TKA and THA at St-Mary's Hospital

Exclusion

  • Known hypersensitivity or allergy to TXA
  • Age \< 18 years
  • 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
  • Known defective colour vision
  • Inability or unwillingness to use MyMobility app
  • Unable to communicate in French or English
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 3 groups in this study.

Groups A, B and C, the comparison group, receive Tranexamic acid.

Registry label: A: 1)Standard care: 1G TXA IV · B: 2) Standard + 1G oral TXA - 0 and 8 hours post-operatively · C: 3) Standard + 1G oral TXA given at 0, 8, 16 and 24 hours post-operatively

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 210 people.

The study is currently expected to finish around July 2027.

The main measurement is taken over: Post-operative.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Step counts at 24 and 48 hours post -operative — measured over Post-operative.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT06208267 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Tranexamic acidDrug

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

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment so the two can be compared.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Post-operative.

The study as a whole is currently expected to finish around 2027-07.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 210 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Montreal, Quebec, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This 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.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.