Comparative Use of Tranexamic Acid Intravenous and Topical Application in Intertrochanteric Fractures With PFNA
Hemorrhage, Fracture Femur
About this trial
This is an interventional treatment trial for Hemorrhage focused on measuring Tranexamic acid, Hemorrhage, Hip fractures, blood transfusion
Eligibility 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.
Sites / Locations
- Hospital das Clinicas Samuel LibanioRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
INTRAVENOUS
LOCAL
PLACEBO
30 patients who will receive 15mg / kg of TXA intravenous in 100ml salina solution (0,9%), after anesthetic induction and before incising the skin (administered in 10 minutes). For masking purposes, these patients will also receive at the end of the surgery, and before performing the plan closure, a compress soaked in 80ml of saline solution (0.9%), which will fill all the plans of the incision, and will be kept for 5 minutes.
30 patients who, at the end of the surgery, and before the suture in layers, will receive a compress soaked in a solution of 1.5 g of tranexamic acid (six ampoules of Transamin®, Zydus Nikkho) diluted in 50 ml of saline solution (0.9 %) (total volume of 80ml), which will fill all the plans of the incision and will be maintained for 5 minutes. For masking purposes, these patients will also receive 100ml of saline solution (0.9%) after anesthetic induction and before incising the skin.
30 patients who will not receive the TXA, but will receive a 100ml intravenous saline solution 0,9% after anesthetic induction and before incising the skin (such as group 1) and a compress soaked in saline solution as used in group 2.