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Completed

NCT Number: NCT04691362

Noninferiority Oral Tranexamic Acid vs Intravenous Administration in Total Hip Arthroplasty

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.

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Key information

Conditions

Hemorrhage Postoperative Arthroplasty Complications Exsanguination Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Total Blood Loss

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Liège

Liège, 4000, Belgium

About this study

Tranexamic acid is an anti-fibrinolytic drug, recommended in total hip arthroplasty to reduce peroperative and postoperative hemorrhagic complications. The original character of our study lies in the serum dosage of tranexamic acid, allowing to correlate the primary objective (blood loss) with this one. The investigators will focus on the reduction of the risks associated with the administration of intravenous medicines, the economic aspect and the ease of use.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA physical status 1, 2 and 3 scheduled for primary total hip arthroplasty

Exclusion criteria

  • Renal failure with serum creatinine level higher than 1,40 mg/dL
  • Thromboembolic events in last 12 months before surgery
  • Pregnancy
  • Congenital or acquired coagulation diseases
  • History of gastric surgery that could lead to malabsorption
  • Diabetic gastro-paresis

Treatment and study plan

Tranexamic Acid Oral Product

Drug

Oral administration of 2 grammes tranexamic acid 2 hours before skin incision and 2 grammes oral tranexamic acid 4 hours after first administration

Tranexamic acid injection

Drug

Intravenous administration of 1 gramme tranexamic acid 30 minutes before skin incision and 1 gramme intravenous tranexamic acid 4 hours after first administration

Primary outcomes

  1. Total blood loss

    Time frame: First 48 hours after surgery

    Peroperative (suction) and postoperative (drainage) total blood loss

Secondary outcomes

  1. Serum concentration of tranexamic acid

    Time frame: 2 hours after oral administration

    Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group

  2. Serum concentration of tranexamic acid

    Time frame: 6 hours after oral administration

    Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group

  3. Serum concentration of tranexamic acid

    Time frame: 30 minutes after intravenous administration

    Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group

  4. Serum concentration of tranexamic acid

    Time frame: 4 hours after intravenous administration

    Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group

  5. Serum hemoglobin variation

    Time frame: 24 hours after surgery

    Variation of serum hemoglobin between preoperative and postoperative period

  6. Serum hemoglobin variation

    Time frame: 72 hours after surgery

    Variation of serum hemoglobin between preoperative and postoperative period

  7. Incidence of blood transfusion

    Time frame: 72 hours after surgery

    Incidence of blood transfusion in two groups

  8. Incidence of thromboembolic complications

    Time frame: 72 hours after surgery

    Incidence of thromboembolic complications such as pulmonary embolism or deep venous thrombosis

  9. Length of hospitalisation stay

    Time frame: 1 week after surgery

    Difference between two groups of total hospitalisation days

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

Study of the Noninferiority of an Oral vs Intravenous Administration of Tranexamic Acid in Total Hip Arthroplasty

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 31, 2020
Registry last updated
Dec 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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