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Antifibrinolytic Agent

Noninferiority Oral Tranexamic Acid vs Intravenous Administration in Total Hip Arthroplasty

Phase 4
Waitlist Available
Research Sponsored by University of Liege
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- ASA physical status 1, 2 and 3 scheduled for primary total hip arthroplasty
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours after intravenous administration
Awards & highlights
Pivotal Trial
No Placebo-Only Group
All Individual Drugs Already Approved
Drug Has Already Been Approved

Summary

To find noninferiority relationship between oral and intravenous administration of tranexamic acid on peroperative and postoperative blood loss and serum concentration during primary total hip arthroplasty.

Eligible Conditions
  • Hemorrhage
  • Joint Replacement Surgery
  • Postoperative Hemorrhage

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 hours after intravenous administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 hours after intravenous administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Total blood loss
Secondary study objectives
Incidence of blood transfusion
Incidence of thromboembolic complications
Length of hospitalisation stay
+2 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Active Control
Group I: Oral Tranexamic AcidActive Control1 Intervention
128 patients scheduled for primary total hip arthroplasty
Group II: Intravenous Tranexamic AcidActive Control1 Intervention
128 patients scheduled for primary total hip arthroplasty

Find a Location

Who is running the clinical trial?

University of LiegeLead Sponsor
265 Previous Clinical Trials
70,252 Total Patients Enrolled
~47 spots leftby Dec 2025
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