Comparative Use of Tranexamic Acid Intravenous and Topical Application in Intertrochanteric Fractures With PFNA

• Status: Recruiting
• Trial end date: 2022-12-18
• Target enrollment: 0
• Participant gender: All

Summary

An intertrochanteric (ITF) trochanteric fracture of the femur is an exclusively extra capsular fracture in which the fracture line extends from the greater trochanter to the lesser trochanter. Its incidence has increased significantly over the past decades and is expected to double in the next 25 years, with an important global economic impact . It affects women in the seventh and eighth decades of life, an age group older than femoral neck fractures. For this reason, the mortality of intertrochanteric fractures is twice that of the femoral neck.

The treatment is surgical, in which the objective is the stable internal fixation and the patient's early ambulation.

Functional outcomes and treatment mortality are related including factors perioperative anemia and blood loss.Even so, even with these precautions, blood loss in this surgical procedure appears to be greater than expected, with blood loss of the order of 2100ml.

Blood loss management and the inherent risks of anemia can be circumvented with blood transfusion. However, blood transfusion is not without risks and complications, such as hypersensitivity and hemolytic reactions, cardiac overload, infectious diseases. Homologous transfusions are associated with prolonged hospital stay, increased costs and increased patient morbidity and mortality.

So, alternatives have been used to avoid the use of blood such as saline solutions, use of erythropoietin and antifibrinolytic agents . Tranexamic acid (TXA) is a drug that interferes with fibrinolysis, in use for more than 50 years in surgery, particularly in cardiac surgery.

Only recently, TXA has sparked interest in orthopedic surgeries. Studies have shown the effectiveness and safety of TXA at FIT, but presented different forms of administration (intravenous, topical, infiltrative) . Despite promising results to contain bleeding in elective orthopedic surgery and fractures, in daily practice, TXA is not very popular, especially in fractures, and has not been used routinely by all doctors. Studies have not been found in the literature about the topical use of TXA compared to intravenous use in FIT.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universidade do Vale do Sapucai
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• Patients of any sex or skin color older than 60 years, admitted for surgical treatment of FIT with indication of fixation with cephalomedullary nails (PFN) in fractures reduced to closed focus.

Exclusion Criteria:

• hypersensitivity to TXA;

• Thrombocytopenia and coagulation disorders: platelets <100,000 or prothrombin activity time (TAP) <70% or activated partial thromboplasty time (APTT)> 40 seconds or International Standardized List (INR)> 1;

• Hepatorenal dysfunction or severe heart disease;

• Previous surgery in the same place;

• Use of anticoagulants and corticoids;

• Pathological fractures of neoplastic origin or duration of neoplastic treatment;

• Autoimmune disease;

• History of pulmonary embolism;

• History of any type of thrombosis (cerebral, in limbs) or stroke;

• Body Mass Index ≥ 40kg / m2 ;

• Patients in need of a second surgical access to reduce the fracture with a direct approach to the fracture focus;

• Diabetes with difficult control.