Efficacy and Safety of Topical Application of Tranexamic Acid for Saving Blood Losses in Patients Subjected to Prosthetic Knee Surgery

NCT ID: NCT03386656

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-28
• Study Completion Date: 2019-05-08

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 loss (estimated blood loss, decreased hemoglobin and Decrease in hematocrit).

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 activity of the tranexamic acid-plasmin complex on fibrin activity is less than the activity of free plasmin alone.

There are two methods of presentation: one, as an injectable solution; Two as a clear, colorless aqueous solution.

Tranexamic acid in Spain is approved for use in the prevention and treatment of bleeding due to general fibrinolysis. As for its specific indications the investigators find that it is used for the treatment of metrorrhagia, menorrhagia, gastrointestinal hemorrhage, urinary hemorrhagic disorders after prostate surgery, surgery of ears, nose, throat, gynecological, thoracic, abdominal or cardiovascular or to counter associated hemorrhages To the administration of a fibrinolytic drug.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Amchafibrin

Estimated total blood loss, measured using the formula described by Nadler. A difference in estimated blood loss greater than or equal to 245 ml will be considered clinically relevant.

Group Type: EXPERIMENTAL

Amchafibrin

Intervention Type: DRUG

Tranexamic acid (Amchafibrin) exerts an antihemorrhagic activity by inhibiting the fibrinolytic properties of plasmin.

Saline Solution 0,9%.

Comparator of tranexamic acid

Group Type: PLACEBO_COMPARATOR

Saline Solution

Intervention Type: OTHER

Placebo

Interventions

Amchafibrin

Tranexamic acid (Amchafibrin) exerts an antihemorrhagic activity by inhibiting the fibrinolytic properties of plasmin.

Intervention Type: DRUG

Saline Solution

Placebo

Intervention Type: OTHER

Other Intervention Names

Placebo

Eligibility 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 subjected to knee arthroplasty surgery.
• Patients signing informed consent, agreeing to participate in the study.

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Pública Andaluza Progreso y Salud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitario Puerta del Mar

Cadiz, , Spain

Countries

Spain

Other Identifiers

FPS-TRA-2017-02

Identifier Type: -

Identifier Source: org_study_id