Comparative Use of Tranexamic Acid Intravenous and Topical Application in Intertrochanteric Fractures With PFNA
90 patients around the world
Available in Brazil
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. Usually, it is an isolated fracture, related to osteoporosis, which occurs
due to low-energy trauma such as a fall during gait. It is the most common fracture of the
proximal femur. 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. The most used materials are plates with dynamic compression
screws (Dinamic Hip Screw-DHS) and intramedullary nails (specifically cephalomedullary nails
or Proximate femoral nail (PFN). Patients who have suffered this fracture are at high risk
for cardiovascular, pulmonary, infections and thrombosis. About a third of patients die in
the first year after the injury, approximately 50% become incapable of walking alone or
climbing stairs and 20% need permanent home care.
Functional outcomes and treatment mortality are related including factors perioperative
anemia and blood loss. In order to prevent blood loss, many strategies have been taken, such
as closed or percutaneous fracture reduction and surgical approach with minimally invasive
techniques such as fixation with short intramedullary nails (PFN). 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. It was also observed that surgeons underestimate the
amount of blood lost in the perioperative period, having estimated a median difference of
1473ml between the apparent blood loss and the one that actually occurred with the use of
cephalomedullary nails. Blood loss in ITF is greater than in femoral neck fractures and more
often requires blood transfusions.
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. Some surgeries may need to wait for the blood supply to be
replenished and patients in need of phenotyped blood find it even more difficult and may wait
days to weeks before finding their proper blood type.
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. Then it has been used in
spine surgery, and joint replacement, without reports of complications. Despite extensive
studies on its use in elective orthopedic surgeries, and its high safety profile, there are
few studies regarding its use in orthopedic trauma surgery. 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.
Universidade do Vale do Sapucai
1Research sites
90Patients around the world
Requirements for the patient
From 60 Years
All Gender
Medical requirements
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.
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.
Sites
Hospital das Clínicas Samuel Libânio - HCSL | Pronto Socorro
Recruiting
R. Comendador José García, 777 - Nova Pouso Alegre, Pouso Alegre - MG, 37550-000, Brazil