Overview
Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss and Transfusion After Total Knee Replacement.
Status:
Completed
Completed
Trial end date:
2019-07-01
2019-07-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study compares two oral medications (tranexamic acid and aminocaproic acid) as hemostatic agent administered in patients undergoing total knee replacement.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Universidad Autonoma de Nuevo LeonTreatments:
Aminocaproic Acid
Tranexamic Acid
Criteria
Inclusion Criteria:1. Age over 18 years
2. Total replacement of the primary knee due to primary Osteoarthrosis
3. Two-compartment prosthesis
4. Unilateral procedure
5. Cemented prosthesis
6. Desire to participate voluntarily in the study and signature of informed consent
7. 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.
8. Possibility for oral administration of the drug.
Exclusion Criteria:
1. History of thrombotic or embolic event in the last 6 months
2. Clinical history of coagulopathy
3. Previous surgeries in the knee to intervene
4. Patients who have received aspirin, platelet or cumarinic antiplatelet agents in the
week prior to surgery or NSAIDs two days prior to surgery.
5. History of myocardial infarction, arteriopathy or unstable angina in the 12 months
prior to surgery.
6. Those patients whose preoperative assessment corresponds to an ASA IV or the procedure
is contraindicated in its preoperative assessment.
7. Total revision knee replacement
8. Total replacement of tumoral knee
9. Total bilateral knee replacement
10. Cognitive deficit
11. Patients who meet the inclusion criteria but do not wish to participate in the study
12. Patients with a diagnosis of Terminal Chronic Kidney Disease or with a serum
creatinine higher than 1.47 mg / dl in the preoperative laboratories.
13. Patients with inability to ingest the drug orally.
14. Patients who are pregnant or breast-feeding or who are taking oral contraceptives.
15. Seizure history
16. Hypersensitivity to the active substance or to any of the excipients.