Tranexamic Acid in Total Hip Arthroplasty.

NCT02252497 | Completed Phase 4 DMC

• 2 other identifiers: 13080152013-000791-15
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Arthroplasty

Keywords

hip arthroplasty; Tranexamic acid; randomized control trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

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

• incidence of symptomatic thrombotic events and death

  in 6 weeks

• tranexamic acid pharmacokinetic analyses

  from the beginning of surgery up to 8 hours

Study Arms (2)

Tranexamic acid

ACTIVE COMPARATOR

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

Drug: Active comparator : Tranexamic Acid (Exacyl)

Physiologic serum

PLACEBO COMPARATOR

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

Drug: Placebo comparator : physiologic serum

Interventions

Active comparator : Tranexamic Acid (Exacyl) DRUG

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

Tranexamic acid

Placebo comparator : physiologic serum DRUG

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

Physiologic serum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Paul ZUFFEREY, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: September 30, 2014
• Study Start: April 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 14, 2016

Record last verified: 2016-03

Locations

FR (1)