Skip to main content
OpenTrials
Completed

NCT Number: NCT02252497

Tranexamic Acid in Total Hip Arthroplasty.

The purpose of this study is to compare a single preoperative dose of 1g of tranexamic acid (TXA) versus a preoperative dose of 1g of TXA followed by a continuous infusion of 1g over height hours on blood loss.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

About this study

The purpose of this study is to compare a single preoperative dose of 1g of tranexamic acid (TXA) versus a preoperative dose of 1g of TXA followed by a continuous infusion of 1g over eight hours on blood loss. The efficacy of TXA on blood loss is greatly influenced by the timing of its administration relative to surgery. In total hip arthroplasty, TXA should be started before surgery. However the optimal duration of TXA administration in hip arthroplasty is unknown. Numerous studies have shown that a single preoperative administration of TXA is effective. Yet indirect comparisons indicate a higher efficacy of TXA started before surgery and followed with a continuous infusion or repeated boluses. Our hypothesis is that a single preoperative administration of TXA is not sufficient to maintain therapeutic concentrations of TXA in the postoperative period. In addition a pharmacokinetic/pharmacodynamic study will be performed to identify the contribution of TXA plasma concentration as a predictor of blood loss.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient requiring hip arthroplasty in first line, except recent hip fracture (less than 3 months)
  • Consent of the patient or a family member or the support person.

Exclusion criteria

  • Contraindication to tranexamic acid.
  • Contraindication to apixaban.
  • Pregnancy.
  • Patient receiving a curative anticoagulating treatment in the preoperative period.

Treatment and study plan

Active comparator : Tranexamic Acid (Exacyl)

Drug
  • 1g Exacyl Intra Venous, just before surgery
  • Then infusion of 1g of Exacyl over eight hours .

Placebo comparator : physiologic serum

Drug
  • 1g Intra Venous just before surgery
  • Then infusion of 1g of physiologic serum over eight hours

Primary outcomes

  1. Calculated volume of blood losses in the peroperative period.

    Time frame: between the beginning of surgery and the fifth day

    It requires the sampling of haemoglobin at the beginning of surgery and in the fifth day.

Secondary outcomes

  1. the patients' percentage that will receive the transfusion of at least one allogenic globular sediment

    Time frame: between D1 (day of surgery) and D5 (the fourth postoperative day)

    the patients' percentage that will receive the transfusion of at least one allogenic globular sediment in the peroperative period.

  2. incidence of symptomatic thrombotic events and death

    Time frame: in 6 weeks

    combined criteria of venous events (deep venous thrombosis or pulmonary embolism), arterial events (acute coronary syndrome, stroke or peripheral arterial thrombosis) and death

  3. tranexamic acid pharmacokinetic analyses

    Time frame: from the beginning of surgery up to 8 hours

    non linear mixt effect model

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Tranexamic Acid in Total Hip Arthroplasty: Single Preoperative Administration vs Perioperative Administration. A Randomized Control Trial.

Acronym: PORTO

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 30, 2014
Registry last updated
Mar 14, 2016

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.

Published trials that share one or more normalized conditions with this study.