Status:
COMPLETED
Efficacy and Safety of Topical Application of Tranexamic Acid for Saving Blood Losses in Patients Subjected to Prosthetic Knee Surgery
Lead Sponsor:
Fundación Pública Andaluza Progreso y Salud
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
To compare the efficacy and safety of topical tranexamic acid versus placebo in patients diagnosed with severe knee osteoarthritis who will undergo prosthetic knee surgery in terms of saving blood los...
Detailed Description
Tranexamic acid (Amchafibrin) exerts an antihemorrhagic activity by inhibiting the fibrinolytic properties of plasmin. Tranexamic acid binds to plasminogen when it is transformed into plasmin. The act...
Eligibility Criteria
Inclusion
- 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 subjected to knee arthroplasty surgery.
- Patients signing informed consent, agreeing to participate in the study.
Exclusion
- 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 consumption coagulopathy.
- 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.
Key Trial Info
Start Date :
November 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2019
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03386656
Start Date
November 28 2017
End Date
May 8 2019
Last Update
January 18 2020
Active Locations (1)
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1
Hospital Universitario Puerta del Mar
Cadiz, Spain, 11009