Tranexamic Acid for Unilateral Total Knee Arthroplasty

Blood Loss Clinical Trial

— TRANEXTOP  

Official title:

Prevention of Postoperative Blood Loss: Randomised Multicentre Parallel Clinical Trial That Assess the Topical and Intravenous Tranexamic Acid in Surgical Patients With a Total Knee Arthroplasty.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594671
• Other study ID #: IIBSP-ATR-2010-23
• Status: Completed
• Phase: Phase 3
• First received: May 3, 2012
• Last updated: December 18, 2012
• Start date: February 2012
• Est. completion date: October 2012

Study information

• Verified date: December 2012
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Blood Loss
• Hemorrhage

Intervention

Drug:
• Tranexamic Acid
Two dosage 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
• 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.

Other:
• haemostasia
The surgical habitual haemostasia: electrocoagulation of the bleeding tissues

Locations

Country	Name	City	State
Spain	Hospital de la Esperanza	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total blood loss (mL)	Blood will be collected by drainages during the first 24 hours after surgery.	at 24 hours postoperatively	No
Secondary	Hidden blood loss	Hidden blood loss will be calculated by Nadler's formula	From admission to hospital until an average of 5 days postoperative period	No
Secondary	Wound complications	We will quantify infections, haematomas and other complications related with surgery	5 weeks postoperatively	Yes
Secondary	Adverse effect related with the interventions	Any adverse effects related with tranexamic acid will be collected	5 weeks postoperatively	Yes