CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY IN ELDERLY PATIENTS WITH PERTROCHANTERIC FRACTURE, RECEIVING TREATMENT WITH TRANEXAMIC ACID IV VS IV+LOCAL IN THE SURGICAL BED.
- Conditions
- pertrochanteric hip fractureMedDRA version: 23.0Level: PTClassification code 10020100Term: Hip fractureSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2022-003163-21-ES
- Lead Sponsor
- Coral Sánchez Pérez
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 102
Patients with pertrochanteric hip fracture admitted to the Gregorio Marañon Hospital during the study period.
Signed written informed consent form.
Men and women aged 65 years or older.
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 102
Fractures of pathological origin (tumor) and those due to polytrauma (2 or more concomitant fractures due to high-energy trauma) and patients with a previous habitual consumption of anticoagulants or antiplatelet drugs will be excluded. The latter will only be excluded from the preelimination analysis to avoid bias, but will be randomized and taken into account at a later stage.
The presence in the anamnesis of all the conditions that are a contraindication for the use of the drug, as listed in the drug's technical data sheet, will be considered exclusion criteria:
Acute arterial or venous thrombosis.
Fibrinolytic diseases after consumption coagulopathy, except in those with predominant activation of the fibrinolytic system with severe acute bleeding.
Severe renal insufficiency (risk of accumulation).
History of seizures.
Analytical data and data obtained in the physical examination.
Hypersensitivity to any component of the study drug formulation.
Any other clinical condition or previous therapy that, in the opinion of the investigator, would make the patient ineligible to participate in the study or unable to comply with the dosing requirements.
Prisoners or persons who are compulsorily detained (involuntary confinement) for the treatment of a psychiatric or physical illness (e.g., an infectious disease) are not eligible to participate in this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to demonstrate the reduction of blood loss with the use of local tranexamic combined with intravenous tranexamic acid;Secondary Objective: - To corroborate the safety of the local use of tranexamic acid in pertrochanteric hip fractures.<br> - To evaluate differences in the length of hospital stay.;Primary end point(s): reduction of blood loss with the use of local tranexamic combined with intravenous tranexamic acid;Timepoint(s) of evaluation of this end point: analytical control the day after surgery
- Secondary Outcome Measures
Name Time Method Secondary end point(s): safety of the local use of tranexamic acid in pertrochanteric hip fractures.<br> differences in the length of hospital stay.;Timepoint(s) of evaluation of this end point: safety: postoperative period, 4-6 weeks and 6 months after surgery<br>Hospital Stay: discharge