Tranexamic Acid in Proximal Humeral Fractures

NCT ID: NCT05437822

Last Updated: 2022-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-29
• Study Completion Date: 2023-06-24

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.

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.

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.

Conditions

Proximal Humeral Fracture; Surgical Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TXA group

Tranexamic acid, a topic dose of 2 g diluted in 50 mL saline solution infused in shoulder joint

Group Type: EXPERIMENTAL

Tranexamic acid

Intervention Type: DRUG

2 g of tranexamic acid in 50 mL of saline

Control group

In the control group will not be administered TXA or any other drugs.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tranexamic acid

2 g of tranexamic acid in 50 mL of saline

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role: collaborator

Elda University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Alejandro Lizaur-Utrilla, PhD, MD

Head of Orthopaedic Surgery Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alejandro Lizaur Utrilla, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Surgery Department, Elda University Hospital

Locations

Elda University Hospital

Elda, Alicante, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Alejandro Lizaur-Utrilla, MD

Role: CONTACT

lizaur1@telefonica.net

+34 966989019

Emilio Sebastia-Forcada, MD

Role: CONTACT

lizaur1@telefonica.net

+34 966989019

Facility Contacts

Alejandro Lizaur-Utrilla, PhD, MD

Role: primary

lizaur1@telefonica.net

+34 966989019

Other Identifiers

TXA-Humeral Fracture

Identifier Type: -

Identifier Source: org_study_id