Tranexamic Acid in Proximal Humeral Fractures

• Status: Recruiting
• Trial end date: 2023-06-24
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect of tranexamic acid (on blood loss and transfusion requirements in patients with proximal humeral fractures requiring open surgical approaches.

This a blinded, controlled, therapeutic trial in which the patients will be randomized to receive TXA or no drug intervention. The primary outcome is the estimated total blood loss.

This study presents only minimal risks for the included patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Elda University Hospital
• Collaborator: Universidad Miguel Hernandez de Elche
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• Acute proximal humeral fracture

• Age over 18 years

Exclusion Criteria:

• ASA IV

• Concomitant fracture

• Refusal to receive blood products

• Allergy for tranexamic acid

• Severe hepatic dysfunction (AST/ALT >60)

• Renal function impairment (serum creatinine > 2 mg/dL or creatinine clearance <30 mL/min),) or kidney transplant

• Active acute thromboembolic event in the past 12 months (Deep Vein Thrombosis, Pulmonary)

• Active coronary artery disease or cerebrovascular accident (event in the past 12 months).

• Coronary stents

• History of hypercoagulability

• Coagulopathy (INR > 1.4)