Epsilon aminocaproic acid and Tranexamic acid in Knee prosthesis

Epsilon Aminocaproic Acid(EACA) and Tranexamic Acid(TXA) in Total Knee Arthroplasty

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-4c6s7s

Enrollment

Unknown

Registered

2018-01-12

Start date

2017-07-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthrosis

Interventions

Group Tranexamic acid: 30 patients will receive a single dose of 1g (20ml) of tranexamic acid directly applied to the knee joint at the end of the prosthesis surgery. Group Epsilon aminocaproic acid:

Drug

D02.241.223.268.860

D02.241.081.193.150.075

Eligibility

Age

40 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients clarified about the research and with knee tricompartmental osteoarthrosis of both sexes; with indication of total knee prosthesis; No diagnosis of inflammatory disease; no history of atrial fibrillation; deep vein thrombosis; previous pulmonary embolism

Exclusion criteria

Exclusion criteria: Use of anticoagulant medications up to seven days before surgery. Anterior surgeries in the same knee with cicatricial alterations that make it impossible to close the joint capsule. Patients who during the operative act require the release of soft parts that are more extensive than the programmed ones that make it impossible to properly close the joint capsule.

Design outcomes

Primary

Measure	Time frame
Expected outcome: Similar bleeding control between groups. The bleeding will be evaluated through statistical analysis using the hemoglobin and serum hematocrit values of the patients. The exams will be collected at the beginning of the anesthesia, immediately before the surgery, after 24 and 48 hours of the procedure.	—

Secondary

Measure	Time frame
Expected outcome 1: A similar clinical and functional outcome between groups, evaluated through the function questionnaire applied before surgery and after 2 months of the procedure, pain scale and gain in the range of motion with analysis before surgery, after 24 and 48 hours, 14 to 21 days and after 2 months ;Expected outcome 2: Lower cost with the use of Epsilon Aminocaproic Acid, evaluated by the amount paid for the medications	—

Measure

Time frame

Expected outcome 1: A similar clinical and functional outcome between groups, evaluated through the function questionnaire applied before surgery and after 2 months of the procedure, pain scale and gain in the range of motion with analysis before surgery, after 24 and 48 hours, 14 to 21 days and after 2 months ;Expected outcome 2: Lower cost with the use of Epsilon Aminocaproic Acid, evaluated by the amount paid for the medications

—

Countries

Brazil

Contacts

Public ContactJoao Guerreiro

Irmandade Santa Casa de Londrina

drjoaopauloguerreiro@gmail.com+554333731000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)