Randomized, placebo-controlled, double-blind trial to evaluate the efficacy and safety of topical application of tranexamic acid for saving blood losses in patients subjected to prosthetic knee surgery.

Phase 1

• Conditions: Knee arthrosis; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2017-002480-17-ES
• Lead Sponsor: Fundación Pública Andaluza Progreso y Salud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-12
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

• Patients of both sexes, in the age group: =18 and =80 years.

• Patients diagnosed with confirmation of severe knee osteoarthritis according to Kellgren criteria (equal or greater than 2) and EVA greater than 7, who will be sujected to knee arthroplasty surgery.

• Patients signing informed consent, agreeing to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

• Patients with concomitant cardiac disease: unstable angina pectoris, acute myocardial infarction, atrial fibrillation, flutter, history of sudden death, severe valve insufficiency.
• Patients with concomitant previous thromboembolic disease: Deep venous thrombosis, pulmonary thromboembolism, thrombotic arterial embolism, Ischemic Vascular Cerebral Stroke, fibrinolytic diseases after coagulopathy consumption.
• Hypersensitivity to tranexamic acid.
• Severe systemic disease: cardio-pulmonary, neurological, renal, infectious or any other type that may impede the development of the study or evaluation of the results.
• History of seizures.
• Patients with severe mental disorder (psychotic disorder, risk of autolysis, manic episode), dependence on toxic substances and / or some physical or psychological limitation to answer.
• Patients receiving oral anticoagulants.
• Patients in litigation for disability claim related or not with the disease.
• Patients who cannot make the necessary visits to carry out the study.
• Patients who refuse to participate or sign informed consent.
• Pregnant and lactating patient’s period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified