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Antifibrinolytic Agent

Tranexamic Acid for Major Joint Replacement Surgery (TXA-Dosing Trial)

Phase 2
Waitlist Available
Led By Angela Jerath
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults > 18 years of age
Elective unilateral hip or knee joint replacement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up perioperative
Awards & highlights

TXA-Dosing Trial Summary

This trial is testing whether a lower dose of a drug given during hip or knee replacement surgery can reduce blood loss and the need for transfusions without increasing the risk of complications.

Who is the study for?
This trial is for adults over 18 who are having elective hip or knee replacement surgery. It's not suitable for those with severe liver disease, allergies to tranexamic acid (TXA), blood clotting disorders, or recent use of anticoagulants.Check my eligibility
What is being tested?
The study aims to find the best dose of TXA during joint replacement surgeries to reduce bleeding and avoid transfusions. Participants will receive standard doses, adjusted if they have kidney issues, and their blood will be sampled throughout the procedure.See study design
What are the potential side effects?
While side effects aren't detailed here, TXA can generally cause nausea, diarrhea, seizures in high doses or allergic reactions. Kidney function monitoring is important as TXA is cleared through the kidneys.

TXA-Dosing Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 years old.
Select...
I am scheduled for a hip or knee replacement surgery.

TXA-Dosing Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and up to 24 hours post-bolus
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and up to 24 hours post-bolus for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood plasma TXA concentration
Secondary outcome measures
% reduction in pre- and postoperative hemoglobin
Hospital length of stay
In-hospital mortality
+2 more

Side effects data

From 2012 Phase 4 trial • 100 Patients • NCT00740116
22%
Readmissions
14%
Postoperative infections
10%
Re-operations
4%
Thromboembolic events
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Group
Tranexamic Group

TXA-Dosing Trial Design

2Treatment groups
Experimental Treatment
Group I: Group IIExperimental Treatment1 Intervention
Participants with GFR ≥ 60 mL/min/1.73m2
Group II: Group IExperimental Treatment1 Intervention
Participants with glomerular filtration rate (GFR) < 60 mL/min/1.73m2 (and dialysis)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid
2018
Completed Phase 4
~42540

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,550,656 Total Patients Enrolled
Angela JerathPrincipal InvestigatorSunnybrook Health Sciences Centre

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate sum of individuals participating in this experiment?

"Affirmative. According to clinicaltrials.gov, the advertised trial is presently recruiting subjects. This research project was first published on December 14th 2021 and subsequently updated on March 14th 2022; 20 participants are being sought from a single site."

Answered by AI

Has enrollment for this research project opened yet?

"According to clinicaltrials.gov, the recruitment for this trial is currently underway; it was first announced on December 14th 2021 and has had its details most recently updated on March 14th 2022."

Answered by AI

To what extent has Tranexamic acid been tested in prior clinical trials?

"Currently, 61 active clinical trials for Tranexamic acid are in progress with 26 of them at Phase 3. These medical studies are taking place across 185 different sites; the vast majority of which is located in Kansas City, Kansas."

Answered by AI

How does Tranexamic acid affect human health in the long-term?

"The safety of tranexamic acid has been assessed and scored a 2, as there is no clinical data to support its efficacy yet. However, the available evidence does verify certain levels of security when it comes to usage."

Answered by AI

What ailments is Tranexamic acid regularly prescribed to address?

"Tranexamic acid is the preferred treatment for hyperfibrinolysis, with supplementary applications in haemophilia management and post-operative bleeding control following tooth extractions."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Tranexamic Acid Dosing for Major Joint Replacement Surgery
2021. "Tranexamic Acid Dosing for Major Joint Replacement Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05075200.
~2 spots leftby Aug 2024
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