Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss After Total Hip Replacement

• Status: Completed
• Trial end date: 2021-04-26
• 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 primary total hip replacement

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Carlos A Acosta-Olivo
• Treatments: Aminocaproic Acid; Tranexamic Acid

Criteria

Inclusion Criteria:

1. Age over 18 years

2. Total replacement of the primary hip due to: 1) Primary Coxarthrosis, 2) Avascular hip necrosis, 3) Transcervical fracture

3. Unilateral procedure

4. Press-fit prosthesis

5. Without the use of cement for the placement of the 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 hip to intervene

4. Patients who have received aspirin, platelet or coumarinic 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. Revision hip replacement

8. Tumoral hip replacement

9. Bilateral hip 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