Tranexamic Acid in Proximal Humeral Fractures

Proximal Humeral Fracture Clinical Trial

Official title:

Effect of Tranexamic Acid in Proximal Humeral Fracture Surgery. A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05437822
• Other study ID #: TXA-Humeral Fracture
• Status: Recruiting
• Phase: Phase 4
• Start date: June 29, 2022
• Est. completion date: June 24, 2023

Study information

• Verified date: June 2022
• Source: Elda University Hospital
• Contact: Alejandro Lizaur-Utrilla, MD
• Phone: +34 966989019
• Email: lizaur1[@]telefonica.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 antifibrinolytic widely used to reduce blood loss in other forms of orthopaedic surgery and in traumatized patients. However, evidence on the effectiveness of TXA in shoulder fractures is more limited. Proximal humeral fractures represent a common orthopedic injury in elderly patients The goal of this study is to assess if the use of topic tranexamic acid in patients with proximal humeral fractures will result in a reduction in blood losses and blood transfusion rates.

The hypothesis is that by providing topic TXA at the end of surgery will decrease the amount of preoperative and intraoperative bleeding thereby leading to a decreased need for postoperative transfusion.

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. Secondary outcomes, need for blood transfusion, length of stay, and rate of thromboembolic events.

Candidates for the study will be consecutive patients with a diagnosis of proximal humeral fracture. All patients meeting inclusion criteria will be recruited for enrollment into the study. Informed consent will be obtained from the patient prior to randomization.

At that time, each patient will be randomized into one of two groups by an independent staff using computer generated randomization and allocation concealment. The two patient groups will include:

1. Study group: 2 g of tranexamic acid topically infused in shoulder joint before surgical closure.

2. Control group: no intervention Both patient groups will be blinded with regard to drug intervention. Patients will be treated surgically with internal fixation or arthroplasty. Blood transfusion criteria will remain consistent with hospital standards (Hb<7 g/dL or >9 g/dL if symptomatic anemia). Total number of blood transfusions received will be documented upon patient discharge.

Deep vein thrombosis (DVT) prophylaxis will remain consistent with hospital standards (subcutaneous heparin from admission until 12 hours prior to surgery and beginning 6 hours after surgery).

Patients will be followed 30 days. Diagnostic studies to assess for thromboembolic events (i.e. DVT, pulmonary embolism (PE), and stroke) will be ordered only if the patient develops clinical signs or symptoms that justify their use.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 24, 2023
• Est. primary completion date: June 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Proximal Humeral Fracture
• Shoulder Fractures
• Surgical Treatment

Intervention

Drug:
• Tranexamic acid
2 g of tranexamic acid in 50 mL of saline

Locations

Country	Name	City	State
Spain	Elda University Hospital	Elda	Alicante

Sponsors (2)

Lead Sponsor	Collaborator
Elda University Hospital	Universidad Miguel Hernandez de Elche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative blood loss	Measurement of loss (in mL), calculated with mathematical formulas proposed by Nadler and Good	Hospital stay, from admission to third postoperative day.
Secondary	Blood transfusion rate	Number of patients needing blood transfusion	Hospital stay, from admission to third postoperative day
Secondary	Infection rate	Number of patients with surgical or medical infections (wound, pneumonia, urinary tract)	90 postoperative days
Secondary	Thrombotic event rate	Number of patients with postoperative thrombotic event (Deep Venous Thrombosis, Pulmonary Embolism, Myocardial Infarction, Stroke)	90 postoperative days.