Tranexamic Acid in Proximal Humeral Fractures

E

Elda University Hospital

Status and phase

Enrolling
Phase 4

Conditions

Proximal Humeral Fracture
Surgical Treatment

Treatments

Drug: Tranexamic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT05437822
TXA-Humeral Fracture

Details and patient eligibility

About

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.

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

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

TXA group
Experimental group
Description:
Tranexamic acid, a topic dose of 2 g diluted in 50 mL saline solution infused in shoulder joint
Treatment:
Drug: Tranexamic acid
Control group
No Intervention group
Description:
In the control group will not be administered TXA or any other drugs.

Trial contacts and locations

1

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Central trial contact

Alejandro Lizaur-Utrilla, MD; Emilio Sebastia-Forcada, MD

Data sourced from clinicaltrials.gov

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