Tranexamic Acid in Total Hip Arthroplasty.

NCT ID: NCT02252497

Last Updated: 2016-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-01-31

Brief Summary

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.

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.

Conditions

Hip Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tranexamic acid

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

Group Type: ACTIVE_COMPARATOR

Active comparator : Tranexamic Acid (Exacyl)

Intervention Type: DRUG

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

Physiologic serum

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

Group Type: PLACEBO_COMPARATOR

Placebo comparator : physiologic serum

Intervention Type: DRUG

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

Interventions

Active comparator : Tranexamic Acid (Exacyl)

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

Intervention Type: DRUG

Placebo comparator : physiologic serum

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul ZUFFEREY, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

CHU de Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2013-000791-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1308015

Identifier Type: -

Identifier Source: org_study_id