Tranexamic Acid for Unilateral Total Knee Arthroplasty

Phase 3

Completed

• Conditions: Blood Loss
• Interventions: Drug: Tranexamic Acid; Other: haemostasia

• Registration Number: NCT01594671
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

Total knee arthroplasty is often associated with excessive postoperative bleeding due to increased fibrinolysis. Hence, the objective of the proposed of this multicentre study is to determine the peri-operative bleeding comparing the application of topical and intravenous tranexamic acid with the habitual surgical haemostasis.

Detailed Description

Objectives:

1. Principal: To assess if the topical and intravenous tranexamic acid reduce less or at least than 20% the blood losses with respect to the habitual haemostasia in patients, after unilateral total knee arthroplasty.

2. Secondary: To assess the treatment safety. To perform a cost- analyses.

Methods: Randomized, multicentre, open and parallel clinical trial with three comparative groups: Topical tranexamic acid, Intravenous tranexamic acid and habitual haemostasia. In all patients, a single drainage of 8mm will be inserted in the joint, and it will remain closed during one hour after the closure of the skin.

Nº of participant centres: 2. Random allocation will be centralised in "Hospital de la Santa Creu i Sant Pau".

Main outcome: Total blood loss (mL) in the post-operative period collected by the habitual drain system ).

Secondary outcomes: Total blood loss (mL)and hidden blood calculated by Nadler's formula. Proportion of patients with blood transfusion, complications of surgery wound, haemoglobin pre and post-operative, units of blood transfused, post-operative mortality, days of hospital stay, safety of interventions assessed.Direct cost analysis.

Substudy: Pharmacokinetic study. The first 24 patients included in "Hospital de la Santa Creu i Sant Pau" for tranexamic acid (12 topical- 12 intravenous) to determine:

1. Plasmatic concentrations of tranexamic acid

2. In topical and intravenous tranexamic acid administration determine the absorption rate and drug bioavailability by these routes: maximum plasma concentration, time to reach Cmax, AUC, and half-life.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-05-03
• Study First Submitted QC: 2012-05-07
• Study First Posted: 2012-05-09
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-18
• Last Update Posted: 2012-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Unilateral Total knee arthroplasty
• The patient consent to participate

Exclusion Criteria

• Antecedent of thromboembolic disease
• Patient with cardiac alterations of the rhythm
• Patients with valvular cardiac prosthesis
• Patients with pro-thrombotic alterations of coagulation
• Treatment with anticonceptive drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid	haemostasia	Intravenous Tranexamic Acid Two dosage Tranexamic acid during the surgical intervention: the first dosage 15-30' before the leg ischemia and the second dosage at 60 -90' after the first dosage. Each dosage: 2 ampoules of 500mg/5 mL/ampoule Other Name: Amchafibrin
Habitual haemostasia	haemostasia	The surgical habitual haemostasia.
Topical Tranexamic acid	haemostasia	Topical Tranexamic acid one dose before the closure of the knee joint: a solution containing 1g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) applied with a syringe diffuser.
Topical Tranexamic acid	Tranexamic Acid	Topical Tranexamic acid one dose before the closure of the knee joint: a solution containing 1g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) applied with a syringe diffuser.
Tranexamic acid	Tranexamic Acid	Intravenous Tranexamic Acid Two dosage Tranexamic acid during the surgical intervention: the first dosage 15-30' before the leg ischemia and the second dosage at 60 -90' after the first dosage. Each dosage: 2 ampoules of 500mg/5 mL/ampoule Other Name: Amchafibrin

Primary Outcome Measures

Name	Time	Method
Total blood loss (mL)	at 24 hours postoperatively	Blood will be collected by drainages during the first 24 hours after surgery.

Secondary Outcome Measures

Name	Time	Method
Hidden blood loss	From admission to hospital until an average of 5 days postoperative period	Hidden blood loss will be calculated by Nadler's formula
Wound complications	5 weeks postoperatively	We will quantify infections, haematomas and other complications related with surgery
Adverse effect related with the interventions	5 weeks postoperatively	Any adverse effects related with tranexamic acid will be collected

Trial Locations

Locations (2)

Hospital de la Esperanza; 🇪🇸 Barcelona, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain