Hip fracture.
Conditions
Interventions
Trade Name: Amchafibrin 500 mg solución inyectable
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: TRANEXAMIC ACID
Other descriptive name: TRANEXAMIC ACID
Concentration unit: mg/kg mil
Sponsors
Asociación Instituto Biodonostia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Who is over 65 years of age, of both sexes. - Accept participation in the study (informed consent that will be signed by the patient or family member / legal representative depending on the degree of autonomy of the patient). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 644
Exclusion criteria
Exclusion criteria: - In treatment with another experimental drug (not participating in another clinical trial with an experimental drug). - The refusal of the patient to participate in the study. - Known allergy to TXA. - Patients with a history of seizures. - Patients with severe kidney and liver failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Compare the efficacy of treatment with tranexamic acid (TXA) in patients with hip fracture, both in hospital admission (intravenously) and perioperatively (local and intravenous), and observe if this translates into a lower rate of blood transfusion.;Secondary Objective: - Evaluate the efficacy of TXA preventive treatment and assess whether this translates into less hidden blood loss during the preoperative period. - Evaluate the efficacy of TXA treatment and assess whether this translates into a decrease in total blood loss. - Evaluate the efficacy of TXA treatment and assess whether it translates into a shorter hospital stay. - Evaluate the presence / absence and difference in the incidence of adverse events.;Primary end point(s): - Blood transfusion The first result of this study will be the transfusion rate from patient admission to hospital discharge. Patients will be monitored with serial measurements of hemoglobin and hematocrit levels, as well as vital signs and symptoms to assess the need for transfusion.;Timepoint(s) of evaluation of this end point: Until patient discharge from hospital | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Hb level: Hb admission, (day 0) Hb day 1, Hb day 2, Hb day 3, Hb preQ, Hb postQ1, Hb postQ2, Hb postQ3. - Hto level. - Occult blood loss: from fracture to admission, and from admission to surgery - Total loss of blood. - Adverse events during hospital admission and 3-6-9-12 months postopitalar: DVT, PE, CVA, heart attack, wound infection, urinary infection, respiratory infection, dementia / delirium, wound hematoma-seroma, readmission , reoperation, transfusion reaction, death. - Troboembolic antecedents. - Charlson comorbidities index. - ASA - Tto. with anticoagulant, antiplatelet medication. - Epidemiological data: age, sex, weight, height. - Time from trauma to hospital admission (in hours). - Previous functionality. - Date of admission. - Date of surgical intervention. - Date of hospital discharge. - Hospital stay. - Type of fracture. - Type of surgical intervention. - Functionality per year.;Timepoint(s) of evaluation of this end point: 24 months | — |
Countries
Spain
Contacts
Public ContactClinical Research Unit
Asociación Instituto Biodonostia
Outcome results
None listed