Patient with a hip fracture and a prosthesis is needed.
Conditions
Sponsors
Institut de Recerca Hospital de la Sant Creu i Sant Pau
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients older than 18 years -Patients with unilateral subcapital femoral fracture -Patients requiring hip replacement (total or partial) -Signature of informed consent from the patient or their legal representative Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: -Multiple fractures -That the patient did not give informed consent or their legal -Known allergy-fibrin glue or tranexamic acid -Background compatible with thromboembolic disease: ? cerebrovascular accident ? Coronary heart disease (myocardial infarction, angina) ? Deep vein thrombosis ? Pulmonary embolism ? peripheral arterial vascular disease ? Patients with thrombogenic arrhythmias ? Patients with prosthetic heart ? Coagulation disorders prothrombotic -Contraceptives, or estrogen therapy - Use of recuperators blood during surgery -Treatment with iron-on post-operative
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether tranexamic acid or fibrin glue administered topically reduce by at least 25% blood loss with respect to control in patients undergoing subcapital fracture of the femur.;Secondary Objective: 1. Hidden blood loss calculated from the formula of Nadler (1962). 2. Proportion of patients requiring blood transfusion in the postoperative 3. Preoperative and postoperative hemoglobin 4. Number. of blood transfusions 5. Units of blood transfusions administered 6. Incidence of wound infection 7. Pain patient's surgical wound 8. Days in hospital 9. Related side effects;Primary end point(s): ? To assess whether tranexamic acid or fibrin glue administered topically reduce at least 25% blood loss with respect to control in patients undergoing subcapital fracture of the femur.;Timepoint(s) of evaluation of this end point: First 24 postoperative hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Hidden blood loss calculated from the formula of Nadler (1962). 2. Proportion of patients requiring blood transfusion in the postoperative 3. Preoperative and postoperative hemoglobin 4. Number. of blood transfusions 5. Units of blood transfusions administered 6. Incidence of wound infection 7. Pain patient's associated with the surgical wound 8. Days in hospital 9. Side effects associated with interventions 10. Hospital mortality;Timepoint(s) of evaluation of this end point: First 5 postoperative days and 1 month after intervention. | — |
Countries
Spain
Contacts
Public ContactRomy Rodríguez
Institut de Recerca Hospital de la Santa Creu i Sant Pau
Outcome results
None listed