E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hip fracture. |
Fractura de cadera. |
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E.1.1.1 | Medical condition in easily understood language |
Hip fracture. |
Fractura de cadera. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- 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. |
- Comparar la eficacia del tratamiento mediante ácido tranexámico (TXA) en pacientes con fractura de cadera, tanto en la admisión hospitalaria (de manera endovenosa) y en el perioperatorio (local y endovenoso), y observar si ésta se traduce en una menor tasa de transfusión sanguínea. |
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E.2.2 | Secondary objectives of the trial |
- 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. |
- Evaluar la eficacia del tratamiento preventivo de TXA y valorar si esta se traduce en una menor pérdida oculta de sangre durante el periodo preoperatorio. - Evaluar la eficacia del tratamiento de TXA y valorar si esta se traduce en una disminución en la pérdida de sangre total. - Evaluar la eficacia del tratamiento de TXA y valorar si esta se traduce en una estancia hospitalaria más corta. - Evaluar la presencia/ausencia y diferencia en la incidencia de acontecimientos adversos. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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). |
- Que sea mayor de 65 años, de ambos sexos. - Aceptar la participación en el estudio (consentimiento informado que será firmado por el paciente o familiar/representante legal dependiendo del grado de autonomía del paciente). |
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E.4 | Principal 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. |
- En tratamiento con otro fármaco experimental (que no esté participando en otro ensayo clínico con un fármaco experimental). - El rechazo del/la paciente a participar en el estudio. - Alergia conocida al TXA. - Pacientes con antecedentes de convulsiones. - Pacientes con insuficiencia renal y hepáticas graves. |
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E.5 End points |
E.5.1 | 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. |
- Transfusión sanguínea El primer resultado de este estudio será la tasa de transfusión desde el ingreso del paciente hasta el alta hospitalaria. Los pacientes serán monitorizados con mediciones seriadas de niveles de hemoglobina y hematocrito, así como signos y síntomas vitales para valorar la necesidad de transfusión. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Until patient discharge from hospital |
Hasta el alta hospitalaria del paciente |
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E.5.2 | 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. |
- Nivel de Hb: Hb ingreso, (día 0) Hb día 1, Hb día 2, Hb día 3, Hb preQ, Hb postQ1, Hb postQ2, Hb postQ3. - Nivel de Hto. - Pérdida de sangre oculta: desde la fractura hasta el ingreso, y desde el ingreso hasta la cirugía - Pérdida total de sangre. - Eventos adversos durante el ingreso hospitalario y a los 3-6-9-12 meses postopitalario: TVP, TEP, ACVA, infarto cardiaco, infección de herida, infección urinaria, infección respiratoria, demencia/delirio, hematoma-seroma de la herida, reingreso, reintervención, reacción transfusional, exitus. - Antecedentes troboembólicos. - Índice de comorbilidades de Charlson. - ASA - Tto. con medicación anticoagulante, antiagregante. - Datos epidemiológicos: edad, sexo, peso, altura. - Tiempo desde el traumatismo hasta el ingreso hospitalario (en horas). - Funcionalidad previa. - Fecha de ingreso. - Fecha de intervención quirúrgica. - Fecha de alta hospitalaria. - Estancia hospitalaria. - Tipo de fractura. - Tipo de intervención quirúrgica. - Funcionalidad al año. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS |
Última visita último paciente |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |