Knee arthrosis
Conditions
Interventions
Trade Name: Amchafibrin
Product Name: tranexamic acid
Pharmaceutical Form: Injection
INN or Proposed INN: tranexamic acid
Other descript
Sponsors
Fundación Pública Andaluza Progreso y Salud
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim objective is to compare the efficacy and safety of topical tranexamic acid versus placebo in patients diagnosed of severe knee osteoarthritis in total primary knee prosthesis, in blood loss decrease (estimated blood loss, low hemoglobin, low hematocrit), and to assess the safety profile of topical tranexamic acid in patients subjected to prosthetic knee surgery.; Secondary Objective: - To evaluate the efficacy and safety of topical tranexamic acid versus placebo in patients diagnosed for severe knee osteoarthritis in total primary knee prosthesis to determine the need of red blood cells transfusion. - To evaluate the functional recovery time in patients treated with topical tranexamic acid with respect to placebo. - To evaluate different indicators of hospital use as the length of hospital stay. ;Primary end point(s): Difference in estimated blood loss greater than or equal to 245 ml.;Timepoint(s) of evaluation of this end point: 24 hour | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 24 hour;Timepoint(s) of evaluation of this end point: 24 hour | — |
Countries
Spain
Contacts
Public ContactMarta Reboredo Ares
Fundación Pública Andaluza Progreso y Salud
Outcome results
None listed