Overview

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)