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 | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10020100 |
E.1.2 | Term | Hip fracture |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
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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 incidence of postoperative delirium and functional gain in terms of the change in the Barthel scale between admission and discharge in patients with hip fracture between treated and untreated patients with intravenous iron. |
Comparar la incidencia de delirium postoperatorio y la ganancia funcional, en términos del cambio en la escala Barthel entre ingreso y alta, en los pacientes con fractura de cadera entre los pacientes tratados y los no tratados con hierro intravenoso.
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E.2.2 | Secondary objectives of the trial |
Secondary objectives: • Evaluate the effectiveness of the administration of intravenous iron in patients with hip fracture to reduce transfusion requirements, both in the percentage of transfused, and the number of packed red blood cells needed. • To evaluate the safety of administration of iron sucrose intravenously. • Compare the number of bacterial infections (urinary, respiratory and surgical) wound between treated and untreated patients with intravenous iron. • Predict whether the treated patients have shorter length of stay hospital that treated. • Estimate whether treatment decreases mortality and readmissions within 30 days of the study patients. |
• Evaluar la eficacia de la administración de hierro intravenoso en los pacientes con fractura de cadera para reducir las necesidades transfusionales, tanto en el porcentaje de transfundidos, como en el número de concentrados de hematíes necesarios. • Evaluar la seguridad de la administración de hierro-sacarosa intravenoso. • Comparar el número de infecciones bacterianas (urinarias, respiratorias y de la herida quirúrgica) entre los pacientes tratados y los no tratados con hierro intravenoso. • Predecir si los pacientes tratados tienen menor tiempo de estancia hospitalaria que los tratados. • Estimar si el tratamiento disminuye la tasa de mortalidad y reingresos a los 30 días de los pacientes del estudio.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients included in the study with hip fracture osteoporotic treated in our unit, with the following characteristics: • Age over 75 years • Having borrowed agreed to participate in the study by signing the corresponding Informed Consent Document.
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Se incluyen en el estudio aquellos pacientes con fractura de cadera osteoporótica atendidos en nuestra unidad, con las siguientes características:
• Edad superior a 75 años
• Haber prestado su conformidad a participar en el estudio mediante firma del correspondiente Documento de Consentimiento Informado.
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E.4 | Principal exclusion criteria |
Exclusion criteria: • Hypersensitivity to oral or parenteral preparations of iron. • Asthma or other severe atopy. • Withdrawal of informed consent. • No indication of surgical fracture |
Criterios de exclusión: • Hipersensibilidad a preparados de hiero parenteral u oral. • Asma u otras atopias severas. • Revocación del consentimiento informado. • No indicación quirúrgica de su fractura |
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E.5 End points |
E.5.1 | Primary end point(s) |
Main efficacy endpoints: • The change in the Barthel scale between admission and discharge (functional gain): • Percentage of patients with "delirium" at some point of stay after surgery.
Description of variables : • Functional Gain: - Barthel index at DISCHARGE - INCOME Barthel index at - A top 5 point difference is considered significant.
• Delirium : presence of delirium from the patient to the ward from the recovery room arrives until he leaves hospital . 1. Acute onset and fluctuating course Have you noticed an acute change in mental status of the patient? If the answer is No, not follow the questionnaire Two . Disturbance in attention Does the patient is easily distracted or have difficulty following a conversation? If the answer is No, not follow the questionnaire 3. Disorganized thinking Does the patient expresses ideas or incoherent conversations or confuse people ? 4. Altered level of consciousness Is altered level of consciousness of the patient ( vigilant , lethargic, stuporous ) ?
For the diagnosis of delirium the first two criteria are necessary and at least one of the two last
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Variables principales de eficacia: • El cambio en la escala Barthel entre ingreso y alta (Ganancia funcional): • Porcentaje de pacientes que presentan “delirium” en algún momento de la estancia tras la cirugía.
Descripción de las variables: • Ganancia funcional: - ÍNDICE DE BARTHEL AL ALTA-ÍNDICE DE BARTHEL AL INGRESO - Una diferencia superior a 5 puntos, se considera significativa.
• Delirium: presencia de delirium desde que llega el paciente a planta procedente de la sala de reanimación, hasta que se va de alta hospitalaria. 1. Comienzo agudo y curso fluctuante ¿Ha observado un cambio agudo en el estado mental del paciente? Si la contestación es No, no seguir el cuestionario 2. Alteración de la atención ¿El paciente se distrae con facilidad o tiene dificultad para seguir una conversación? Si la contestación es No, no seguir el cuestionario 3. Pensamiento desorganizado ¿El paciente manifiesta ideas o conversaciones incoherentes o confunde a las personas? 4. Alteración del nivel de conciencia ¿Está alterado el nivel de conciencia del paciente (vigilante, letárgico, estuporoso)? Para el diagnóstico de delirium son necesarios los dos primeros criterios y por lo menos uno de los dos últimos.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Description of variables:
• Functional Gain:
- Barthel index at DISCHARGE-ADMISSION Barthel index
• Delirium: presence of delirium from the patient to the ward from the recovery room arrives until he leaves hospital discharge. |
Descripción de las variables: • Ganancia funcional: - ÍNDICE DE BARTHEL AL ALTA-ÍNDICE DE BARTHEL AL INGRESO
• Delirium: presencia de delirium desde que llega el paciente a planta procedente de la sala de reanimación, hasta que se va de alta hospitalaria.
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E.5.2 | Secondary end point(s) |
Secondary efficacy endpoints: • Functional Efficiency defined as Barthel index at DISCHARGE-ADMISSION Barthel index at / LENGTH OF STAY postsurgical.
• Change in functional scale (WALKING) Red Cross between admission and discharge.
• Percentage of patients required transfusion (pre, intra, post) and number of concentrates at all times
• Percentage of patients with bacterial infections (urinary, respiratory and surgical wound) during admission
• Length of stay (preoperative and global)
• Mortality during stay
• Readmission within 30 days after discharge.
Security Variables:
• Blood transfusion
• Side effects following administration of intravenous iron.
Secondary efficacy endpoints : • Functional Efficiency defined as Barthel index at DSICHARGE-ADMISSION Barthel index at / LENGTH OF STAY postsurgical .
• Change in functional scale ( WANDERING ) Red Cross between admission and discharge *
• Percentage of patients required transfusion (pre , intra and postoperative ) and number of concentrates at all times
• Percentage of patients with bacterial infections ( urinary, respiratory and surgical wound) during admission
• Length of stay ( preoperative and global)
• Mortality during stay
• Readmission within 30 days after discharge.
Security Variables : • Blood transfusion • Side effects following administration of intravenous iron .
* Modified Barthel Index evaluates 11 items and each is scored as reflected in parentheses: 1. Washing: ( 0 , 1, 3 , 4, 5 ) 2. Swimming: ( 0 , 1, 3 , 4, 5 ) 3. Eat (0, 2 , 5, 8 , 10) 4. Using the toilet ( 0 , 2, 5 , 8, 10 ) 5. Climbing stairs (0, 2 , 5, 8 , 10) 6. Dressing ( 0 , 2, 5 , 8, 10 ) 7. Control stool ( 0 , 2, 5 , 8, 10 ) 8. Urine Control ( 0 , 2, 5 , 8, 10 ) 9. Scroll ( 0 , 3, 8 , 12, 15 ) 10. Wheelchair ( 0 , 1, 3 , 4, 5 ) 11. Chair bed ( 0, 3 , 8, 12, 15 ) Transfer (0, 3, 8, 12, 15)
Functional Scale ** Red Cross : 0 . Was totally worth by itself. Walking normally. 1. Enough Performs the actions of everyday life. Wander with some difficulty. Total continence. 2 . Having Difficulty in daily acts , so sometimes you need help . Wander using cane or similar. Rare full continence or incontinence. 3 . Grave difficulty in many acts of daily life. Wander hard, helped at least one person . Occasional incontinence . 4 . Need Help for almost every event . Wander helped with extreme difficulty ( 2 people). Habitual incontinence. 5. Plant or couch at home . Total incontinence . You need continuous nursing care
Adverse effects of iron *** : - Categorized NO / YES - Hypotension , fever, tremors , reactions at the injection site , nausea , rash and pruritus. Other (specify ) |
Variables secundarias de eficacia: • Eficiencia funcional definida como: ÍNDICE DE BARTHEL AL ALTA-ÍNDICE DE BARTHEL AL INGRESO/ESTANCIA POSTQUIRÚRGICA.
• Cambio en la escala funcional (marcha) Cruz Roja entre ingreso y alta*
• Porcentaje de pacientes de necesitan transfusión (pre, intra y postcirugía) y número de concentrados en cada momento
• Porcentaje de pacientes que presentan infecciones bacterianas (urinarias, respiratorias y de la herida quirúrgica) durante el ingreso
• Duración de la estancia (prequirúrgica y global)
• Mortalidad durante la estancia
• Reingreso durante los 30 días siguientes tras el alta.
Variables de Seguridad: • Transfusión sanguínea • Efectos secundarios tras la administración del hierro intravenoso.
*Indice de Barthel Modificado: evalúa 11 items y cada uno de ellos se puntúa como se refleja entre paréntesis: 1. Aseo personal: (0 ,1, 3, 4, 5) 2. Bañarse: (0 ,1, 3, 4, 5) 3. Comer (0, 2, 5, 8, 10) 4. Usar el retrete (0, 2, 5, 8, 10) 5. Subir escaleras (0, 2, 5, 8, 10) 6. Vestirse (0, 2, 5, 8, 10) 7. Control de heces (0, 2, 5, 8, 10) 8. Control de orina (0, 2, 5, 8, 10) 9. Desplazarse (0, 3, 8, 12, 15) 10. Silla de ruedas (0, 1, 3, 4, 5) 11. Traslado silla- cama (0, 3, 8, 12, 15)
** Escala de Cruz Roja Funcional: 0. Se vale totalmente por sí mismo. Anda con normalidad. 1. Realiza suficientemente los actos de la vida diaria. Deambula con alguna dificultad. Continencia total. 2. Tiene alguna dificultad en los actos diarios, por lo que, en ocasiones, necesita ayuda. Deambula con ayuda de bastón o similar. Continencia total o rara incontinencia. 3. Grave dificultad en bastantes actos de la vida diaria. Deambula difícilmente, ayudado al menos por una persona. Incontinencia ocasional. 4. Necesita ayuda para casi todos los actos. Deambula ayudado con extrema dificultad (2 personas). Incontinencia habitual. 5. Inmovilizado en casa o sillón. Incontinencia total. Necesita cuidados continuos de enfermería
***Efectos adversos del hierro: - Categorizados NO / SI - Hipotensión, fiebre y temblores, reacciones en el punto de inyección, náuseas, erupción cutánea y prurito. Otras (especificar)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Functional Efficiency defined as Barthel index at ADMISSION-DISCHARGE Barthel index at / LENGTH OF STAY postsurgical. • Functional Scale (WALKING) Red Cross: measured at admission and at discharge. • Transfusion: Preoperative, intraoperative and postoperative. • Patients who have side effects to intravenous iron during admission. • Percentage of patients with bacterial infections (urinary, respiratory and surgical wound) during admission • Preoperative stay: days from admission to the day of surgery. • Global Stay: days from admission to discharge. • Mortality during hospital stay. • Readmission for medical or surgical cause during the 30 days after discharge. |
• Eficiencia funcional definida como: ÍNDICE DE BARTHEL AL ALTA-ÍNDICE DE BARTHEL AL INGRESO/ESTANCIA POSTQUIRÚRGICA. • Escala funcional (marcha) de Cruz Roja: medida al ingreso y al alta. • Transfusión: Preoperatoria, intraoperatoria y postoperatoria • Pacientes que presentan efectos secundarios a hierro intravenoso durante el ingreso. • Porcentaje de pacientes que presentan infecciones bacterianas (urinarias, respiratorias y de la herida quirúrgica) durante el ingreso • Estancia prequirúrgica: días desde el ingreso hasta el día de la cirugía. • Estancia Global: días desde el ingreso hasta el alta. • Mortalidad durante la estancia hospitalaria. • Reingreso por causa clínica o quirúrgica durante los 30 días siguientes tras el alta.
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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 | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |