Status:
UNKNOWN
Tranexamic Acid in Proximal Humeral Fractures
Lead Sponsor:
Elda University Hospital
Collaborating Sponsors:
Universidad Miguel Hernandez de Elche
Conditions:
Proximal Humeral Fracture
Surgical Treatment
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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. Thi...
Detailed Description
Studies have shown that hip fractures have a significant perioperative blood loss. Postoperative anaemia is associated with a higher morbidity and mortality. Tranexamic acid is a safe and effective a...
Eligibility Criteria
Inclusion
- Acute proximal humeral fracture
- Age over 18 years
Exclusion
- 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)
Key Trial Info
Start Date :
June 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 24 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05437822
Start Date
June 29 2022
End Date
June 24 2023
Last Update
July 5 2022
Active Locations (1)
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1
Elda University Hospital
Elda, Alicante, Spain, 03600