Tranexamic Acid in Total Hip Arthroplasty.

Hip Arthroplasty Clinical Trial

— PORTO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02252497
• Other study ID #: 1308015
• Secondary ID: 2013-000791-15
• Status: Completed
• Phase: Phase 4
• First received: September 26, 2014
• Last updated: March 11, 2016
• Start date: April 2014
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Arthroplasty

Intervention

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

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	SAINT-ETIENNE cedex 2

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	No
Secondary	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	Yes
Secondary	tranexamic acid pharmacokinetic analyses	non linear mixt effect model	from the beginning of surgery up to 8 hours	Yes