Status:
UNKNOWN
Comparative Use of Tranexamic Acid Intravenous and Topical Application in Intertrochanteric Fractures With PFNA
Lead Sponsor:
Universidade do Vale do Sapucai
Conditions:
Hemorrhage
Fracture Femur
Eligibility:
All Genders
60+ years
Phase:
NA
Brief 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 inc...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 18 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04696224
Start Date
December 18 2020
End Date
December 18 2022
Last Update
November 4 2022
Active Locations (1)
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1
Hospital das Clinicas Samuel Libanio
Pouso Alegre, Minas Gerais, Brazil, 37550000