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Evaluating the Effectiveness of Intramuscular Versus Intravenous Tranexamic Acid for Minimizing Blood Loss After Total Hip Arthroplasty: A Randomized Controlled Trial

ConditionBlood Loss After a Total Hip Replacement
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlexandria University

About this trial

Intramuscular vs. Intravenous Tranexamic Acid for Total Hip Arthroplasty

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult patients aged 18 years and older.

Scheduled to undergo elective primary total hip arthroplasty.

Able to provide informed consent.

Disqualifiers

1. History of renal failure or kidney transplant. 2. History of an arterial thromboembolic event (such as myocardial infarction or stroke) within the past year.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tranexamic Acid (TXA) intarmuscular

    Drug

    Tranexamic acid 1 gram administered via deep intramuscular injection into the lateral thigh or deltoid muscle prior to surgery.

  • Tranexamic Acid (TXA) intravenous

    Drug

    Tranexamic acid 1 gram administered intravenously over 10 minutes, following standard protocols, prior to surgery.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Intramuscular TXAExperimental treatment 1 intervention
Group B: Intravenous TXAActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change of Hemoglobin Concentration

Time frame
From baseline (preoperative) up to hospital discharge (typically 3-5 days postoperatively).

Secondary outcomes

1

Postoperative Calculated Blood Loss

Volume of total blood loss calculated as a function of patient characteristics (sex, height, weight) and perioperative hemoglobin balance using standard Gross and Nadler mathematical formulas.

Time frame
From day 1 Up to hospital discharge.
2

Postoperative Calculated Hemoglobin Loss

Total mass of hemoglobin loss calculated based on patient baseline physical parameters and perioperative hemoglobin balance.

Time frame
From day 1 Up to hospital discharge.
3

Number of Blood Units Transfused

The total cumulative units of blood products administered per patient.

Time frame
From the start of surgery at day 1 up to hospital discharge.
4

Blood Transfusion Rate

The percentage/proportion of patients requiring allogeneic blood transfusion.

Time frame
From day 1 at the start of surgery up to hospital discharge

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexandria University

Lead sponsor

Source ClinicalTrials.gov
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