pertrochanteric hip fracture MedDRA version: 23.0 Level: PT Classification code 10020100 Term: Hip fracture System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Trade Name: AMCHAFIBRIN
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Tranexamic acid
Other descriptive name: Tranexamic acid
Concentration unit: g gram(s)
Concentration type: equal
Sponsors
Coral Sánchez Pérez
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. - 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): safety of the local use of tranexamic acid in pertrochanteric hip fractures. 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 Hospital Stay: discharge | — |
Countries
Spain
Contacts
Public ContactJaime Flores
Jaime Flores
Outcome results
None listed