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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
150
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
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.
The surgical habitual haemostasia: electrocoagulation of the bleeding tissues
Hospital de la Esperanza
Barcelona, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Total blood loss (mL)
Blood will be collected by drainages during the first 24 hours after surgery.
Time frame: at 24 hours postoperatively
Hidden blood loss
Hidden blood loss will be calculated by Nadler's formula
Time frame: From admission to hospital until an average of 5 days postoperative period
Wound complications
We will quantify infections, haematomas and other complications related with surgery
Time frame: 5 weeks postoperatively
Adverse effect related with the interventions
Any adverse effects related with tranexamic acid will be collected
Time frame: 5 weeks postoperatively
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