Tranexamic Acid in Total Hip Arthroplasty. (PORTO)

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Completed; Phase 4

Conditions: Hip Arthroplasty

Treatments: Drug: Placebo comparator : physiologic serum; Drug: Active comparator : Tranexamic Acid (Exacyl)

Study type: Interventional

Funder types: Other

Identifiers

NCT02252497

1308015

2013-000791-15 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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168 participants in 2 patient groups, including a placebo group

Tranexamic acid

Active Comparator group

Description:

* 1g Intra Venous just before surgery * Then infusion of 1g of Exacyl over eight hours.

Treatment:

Drug: Active comparator : Tranexamic Acid (Exacyl)

Physiologic serum

Placebo Comparator group

Description:

* 1g Intra Venous, just before surgery * Then infusion of 1g of physiologic serum over eight hours.

Treatment:

Drug: Placebo comparator : physiologic serum