E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Anemia in patients with chronic lower limb ischemia |
Anemia en pacientes con isquemia crónica de miembros inferiores |
|
E.1.1.1 | Medical condition in easily understood language |
Anemia in patients with chronic lower limb ischemia |
Anemia in patients with chronic lower limb ischemia |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002272 |
E.1.2 | Term | Anemia |
E.1.2 | System Organ Class | 100000004851 |
|
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 |
Reduce the incidence of transfusion from randomization up to 30 days after the main surgery in patients with anemia who undergo revascularization surgery with chronic lower limb ischemia |
Reducir la incidencia de transfusión desde la randomización hasta 30 días después de la cirugía principal en pacientes con anemia que son sometidos a cirugía de revascularización con isquemia crónica de miembros inferiores |
|
E.2.2 | Secondary objectives of the trial |
-Changes and evolution of hemoglobin during admission; difference in hemoglobin (Hb) between inclusion, intervention and discharge. Hb 30 days after discharge -Establish the optimal preoperative moment of increased intravenous iron yield to increase Hb -Impact of anemia and its treatment on the length of hospital stay, morbidity and mortality and quality of life during admission and first 30 days postoperatively |
-Cambios y evolución de la hemoglobina durante el ingreso; diferencia en la hemoglobina (Hb) entre la inclusión, la intervención y el alta. Hb a los 30 días del alta -Establecer el momento preoperatorio óptimo de mayor rendimiento del hierro intravenoso para aumentar la Hb -Impacto de la anemia y su tratamiento sobre la duración de la estancia hospitalaria, morbimortalidad y calidad de vida durante el ingreso y primeros 30 días postoperatorios |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Patients of both sexes over 18 years -Patients diagnosed with anemia, considered as , Hb <13.0 g/dL in mens and Hb<12g/dL in women -Patients diagnosed with symptomatic chronic lower limb ischemia (degrees 2-5 by Rutherford-Baker, both included, Fontaine II-IV), who will undergo surgical revascularization (endovascular or open) and accept treatment - Revascularization surgery scheduled in the approximate minimum period of one week, (> 7 days) from the inclusion -They are able and willing to give written informed consent at the time of selection |
-Pacientes de ambos sexos mayores de 18 años -Pacientes diagnosticados con anemia, considerada como, Hb <13.0 g/dL en hombres y Hb<12g/dL en mujeres -Pacientes diagnosticados de isquemia crónica de miembros inferiores sintomática (grados 2-5 de Rutherford-Baker, ambos incluidos; II-IV de Fon-taine), que vayan a ser sometidos a revascularización quirúrgica (endovascular o abierta) y que acepten el tratamiento -Cirugía de revascularización programada en el plazo aproximado mínimo de una semana, (>7 días) desde la inclusión -Que sean capaces y estén dispuestos a dar el consentimiento informado por escrito en el momento de la selección |
|
E.4 | Principal exclusion criteria |
-Patients with acute ischemia will be excluded -Severe anemia < 8 gr/dL -Arterial hypertension not controlled with antihypertensive medication (considered with systolic blood pressure> 180mmHg or diastolic> 100mmHg) - Acute renal failure or renal failure with creatinine clearance <30mmHg -Patient with documented intolerance or allergy to iron or its derivatives -Unstable angina, defined as electrocardiographic changes with chest pain that indicate resting myocardial ischemia -History of stroke in the previous 6 months -Patients with thrombocytopenia less than 50,000ug/dl or alterations in coagulation -That you are simultaneously participating in a clinical trial that conditions or modifies the registry -Patients already diagnosed with iron-deficiency anemia in oral iron treatment in their usual medication -Pregnancy or lactation (pregnancy tests in women of childbearing age according to usual practice) -Rejection of treatment or inclusion in the registry by the patient -Patients who refuse to receive transfusions of blood products (for example, Jehovah's Witnesses) -Patients with criteria of SEPSIS -Patients with Ferritin <30 ng/ml that will be directed for digestive study -Patients with active neoplasia -Patients who are not able to give their informed consent or understand the study procedure |
-Se excluirán los pacientes con isquemia aguda -Anemia grave < 8 gr/dL -Hipertensión arterial no controlada con la medicación antihipertensiva (considerada con tensión sistólica >180mmHg o diastólica >100mmHg) -Fallo renal agudo o insuficiencia renal con aclaramiento de creatinina <30mmHg -Paciente con intolerancia o alergia documentada al hierro o sus derivados -Angina inestable, definida como cambios electrocardiográficos con dolor torácico que indiquen isquemia miocárdica en reposo -Historia de ictus en los 6 meses previos -Pacientes con trombocitopenia menor de 50.000ug/dl o alteraciones en la coagulación. -Que simultáneamente esté participando en un ensayo clínico que condicione o modifique el registro -Pacientes ya diagnosticados de anemia ferropénica en tratamiento con hierro vía oral en su medicación habitual -Embarazo o lactancia (pruebas de embarazo en mujeres en edad fértil según práctica habitual) -Rechazo del tratamiento o de la inclusión en el registro por parte del paciente -Pacientes que se nieguen a recibir transfusiones de hemoderivados (por ejemplo; testigos de Jehovah) -Pacientes con criterios de SEPSIS -Pacientes con Ferritina <30 ng/mL qué serán dirigidos para estudio digestivo -Pacientes con neoplasia activa -Pacientes que no sean capaces de dar su consentimiento informado o entender el procedimiento del estudio |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Reduce the incidence of transfusion from randomization up to 30 days after the main surgery in patients with anemia who undergo revascularization surgery with chronic lower limb ischemia |
Reducir la incidencia de transfusión desde la randomización hasta 30 días después de la cirugía principal en pacientes con anemia que son sometidos a cirugía de revascularización con isquemia crónica de miembros inferiores |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Yes |
E.8.2.2 | Placebo | No |
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
|
The end of the trial it is the last visit of the last subject undergoing the trial |
El final del ensayo es la última visita del último sujeto sometido al ensayo |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |