Blood Loss
Conditions
Keywords
primary knee arthroplasty, tranexamic acid, topical
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.
Interventions
DRUGTranexamic 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
OTHERhaemostasia
The surgical habitual haemostasia: electrocoagulation of the bleeding tissues
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total blood loss (mL) | at 24 hours postoperatively | Blood will be collected by drainages during the first 24 hours after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Outcome results
None listed