Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss and Transfusion After Total Knee Replacement.

• Status: Completed
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: 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 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad Autonoma de Nuevo Leon
• Treatments: 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.