Status:
COMPLETED
Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss and Transfusion After Total Knee Replacement.
Lead Sponsor:
Universidad Autonoma de Nuevo Leon
Conditions:
Knee Osteoarthritis
Blood Clot
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
This study compares two oral medications (tranexamic acid and aminocaproic acid) as hemostatic agent administered in patients undergoing total knee replacement.
Detailed Description
Background Total knee arthroplasty is the most common orthopedic procedure in knee surgery for the treatment of degenerative diseases such as OA and rheumatoid arthritis (RA), with nearly 700,000 pro...
Eligibility Criteria
Inclusion
- Age over 18 years
- Total replacement of the primary knee due to primary Osteoarthrosis
- Two-compartment prosthesis
- Unilateral procedure
- Cemented prosthesis
- Desire to participate voluntarily in the study and signature of informed consent
- Pre-operative assessment with result between ASA I, ASA II or ASA III performed and annexed in the clinical file either by the Department of Internal Medicine, Cardiology or Anesthesiology of our hospital.
- Possibility for oral administration of the drug.
Exclusion
- History of thrombotic or embolic event in the last 6 months
- Clinical history of coagulopathy
- Previous surgeries in the knee to intervene
- Patients who have received aspirin, platelet or cumarinic antiplatelet agents in the week prior to surgery or NSAIDs two days prior to surgery.
- History of myocardial infarction, arteriopathy or unstable angina in the 12 months prior to surgery.
- Those patients whose preoperative assessment corresponds to an ASA IV or the procedure is contraindicated in its preoperative assessment.
- Total revision knee replacement
- Total replacement of tumoral knee
- Total bilateral knee replacement
- Cognitive deficit
- Patients who meet the inclusion criteria but do not wish to participate in the study
- Patients with a diagnosis of Terminal Chronic Kidney Disease or with a serum creatinine higher than 1.47 mg / dl in the preoperative laboratories.
- Patients with inability to ingest the drug orally.
- Patients who are pregnant or breast-feeding or who are taking oral contraceptives.
- Seizure history
- Hypersensitivity to the active substance or to any of the excipients.
Key Trial Info
Start Date :
October 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT03365999
Start Date
October 15 2017
End Date
July 1 2019
Last Update
July 30 2019
Active Locations (1)
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1
Facultad de Medicina UANL
Monterrey, Nuevo León, Mexico, 1-4469