Tranexamic Acid in Proximal Humeral Fractures

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

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.

Study Overview

• Status: Recruiting
• Conditions: Proximal Humeral Fracture; Surgical Treatment
• Intervention / Treatment: Drug: Tranexamic acid

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 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Alejandro Lizaur-Utrilla, MD; Phone Number: +34 966989019; Email: lizaur1@telefonica.net
• Study Contact Backup: Name: Emilio Sebastia-Forcada, MD; Phone Number: +34 966989019; Email: lizaur1@telefonica.net

Study Locations

• Spain
  • Alicante
    • Elda, Alicante, Spain, 03600
      • Recruiting
      • Elda University Hospital
      • Principal Investigator: Alejandro Lizaur-Utrilla, PhD, MD
      • Contact: Alejandro Lizaur-Utrilla, PhD, MD; Phone Number: +34 966989019; Email: lizaur1@telefonica.net
      • Sub-Investigator: Emilio Sebastia-Forcada, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TXA group; Tranexamic acid, a topic dose of 2 g diluted in 50 mL saline solution infused in shoulder joint	Drug: Tranexamic acid; 2 g of tranexamic acid in 50 mL of saline
NO_INTERVENTION: Control group; In the control group will not be administered TXA or any other drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood transfusion rate	Number of patients needing blood transfusion	Hospital stay, from admission to third postoperative day
Infection rate	Number of patients with surgical or medical infections (wound, pneumonia, urinary tract)	90 postoperative days
Thrombotic event rate	Number of patients with postoperative thrombotic event (Deep Venous Thrombosis, Pulmonary Embolism, Myocardial Infarction, Stroke)	90 postoperative days.

Collaborators and Investigators

• Sponsor: Elda University Hospital
• Collaborators: Universidad Miguel Hernandez de Elche
• Investigators: Principal Investigator: Alejandro Lizaur Utrilla, MD, Orthopaedic Surgery Department, Elda University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 29, 2022
• Primary Completion (ANTICIPATED): June 21, 2023
• Study Completion (ANTICIPATED): June 24, 2023

Study Registration Dates

• First Submitted: June 18, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (ACTUAL): June 29, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Tranexamic acid; surgical treatment; proximal humeral fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures; Shoulder Fractures; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: TXA-Humeral Fracture

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No