Tranexamic Acid in Total Hip Arthroplasty. (PORTO)

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

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.

Study Overview

• Status: Completed
• Conditions: Hip Arthroplasty
• Intervention / Treatment: Drug: Active comparator : Tranexamic Acid (Exacyl); Drug: Placebo comparator : physiologic serum

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • SAINT-ETIENNE cedex 2, France, 42055
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tranexamic acid; 1g Intra Venous just before surgery; Then infusion of 1g of Exacyl over eight hours.	Drug: Active comparator : Tranexamic Acid (Exacyl); 1g Exacyl Intra Venous, just before surgery; Then infusion of 1g of Exacyl over eight hours .
Placebo Comparator: Physiologic serum; 1g Intra Venous, just before surgery; Then infusion of 1g of physiologic serum over eight hours.	Drug: Placebo comparator : physiologic serum; 1g Intra Venous just before surgery; Then infusion of 1g of physiologic serum over eight hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculated volume of blood losses in the peroperative period.	It requires the sampling of haemoglobin at the beginning of surgery and in the fifth day.	between the beginning of surgery and the fifth day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the patients' percentage that will receive the transfusion of at least one allogenic globular sediment	the patients' percentage that will receive the transfusion of at least one allogenic globular sediment in the peroperative period.	between D1 (day of surgery) and D5 (the fourth postoperative day)
incidence of symptomatic thrombotic events and death	combined criteria of venous events (deep venous thrombosis or pulmonary embolism), arterial events (acute coronary syndrome, stroke or peripheral arterial thrombosis) and death	in 6 weeks
tranexamic acid pharmacokinetic analyses	non linear mixt effect model	from the beginning of surgery up to 8 hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Paul ZUFFEREY, MD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: September 26, 2014
• First Submitted That Met QC Criteria: September 26, 2014
• First Posted (Estimate): September 30, 2014

Study Record Updates

• Last Update Posted (Estimate): March 14, 2016
• Last Update Submitted That Met QC Criteria: March 11, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: randomized control trial; Tranexamic acid; hip arthroplasty
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 1308015; 2013-000791-15 (EudraCT Number)