E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with bone tumor undergoing massive resection. |
Pacientes con tumor óseo que son sometidos a una resección importante. |
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E.1.1.1 | Medical condition in easily understood language |
Patients with bone tumor undergoing massive bone resection. |
Pacientes con tumor óseo que son sometidos a una resección importante. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
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 |
To assess if the fibrin glue or the topic tranexamic acid reduce at least 35% the blood losses after surgery with respect to the normal haemostasia in patients undergoing massive bone resection. |
Evaluar si la cola de fibrina o el ácido tranexámicoadministrado vía tópica reduce al menos en un 35% la pérdida sanguínea con respecto al grupo control en pacientes a los que se practica una resección de sarcoma óseo. |
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E.2.2 | Secondary objectives of the trial |
1. Proportion of patients requiring blood transfusion in the postoperative period 2. Preoperative and postoperative hemoglobin 3. Number of blood transfusions 4. Number of units of blood transfusion administered 5. Incidence of wound infection 6. Incidence of seroma formation 7. Pain patient's at the surgical wound 8. Days in hospital 9. Side effects associated with interventions 10. Local recurrence rate 11. Distant metastasis rate |
1. Proporción de pacientes que necesitan transfusión sanguínea en el postoperatorio 2. Hemoglobina pre y postoperatoria 3. Número de transfusiones sanguíneas 4. Número de unidades de transfusión sanguínea administradas 5. Incidencia de infección de la herida 6. Incidencia de formación de seroma 7. Dolor de la herida quirúrgica del paciente 8. Días de estancia hospitalaria 9. Efectos secundarios relacionados con las intervenciones 10. Tasa de recidiva local 11. Tasa de diseminación a distancia |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Patients over 18 years 2) Bone tumor (primary or metastatic, benign or malignant) alocated in the extremities, or the pelvic or shoulder girdles. 3) Massive or block resection of bone tumor. 4) Signature of the patient's informed consent |
1) Pacientes mayores de 18 años 2) Tumor óseo (primario o metastásico, benigno o maligno) localizado en las extremidades o en la cintura pelviana o escapular. 3) Resección masiva o en bloque de tumor óseo . 4) Firma del consentimiento informado del paciente |
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E.4 | Principal exclusion criteria |
1) Allergy to tranexamic acid or fibrin glue 2) Background compatible with thromboembolic disease: ? Stroke ? Ischemic heart disease ? Deep vein thrombosis and / or superficial ? Pulmonary thromboembolism ? Peripheral arterial vascular disease ? Iron therapy in post-operative period ? Use of recuperatorsof blood during surgery ? Patients with thrombogenic arrhythmias ? Patients with prosthetic heart ? Coagulation disorders prothrombotic ? Treatment with contraceptive drugs |
1) Alergia conocida al ácido tranexámico o a la cola de fibrina 2) Antecedentes compatibles con enfermedad tromboembólica: ? Accidente vascular cerebral ? Cardiopatía isquémica ? Trombosis venosa profunda y/o superficial ? Tromboembolismo Pulmonar ? Vasculopatía arterial periférica ? Tratamiento con hierro en el post-operatorio ? Uso de recuperadores de sangre durante la intervención quirúrgica ? Pacientes con arritmias trombogénicas (ejem.: ACxFA) ? Pacientes portadores de prótesis cardiovasculares ? Alteraciones de la coagulación protrombóticas ? Tratamiento con fármacos anticonceptivos |
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E.5 End points |
E.5.1 | Primary end point(s) |
Amount (ml) of blood loss after surgery quantified the first 48 hours postoperatively. |
Cantidad (en ml) de pérdida sanguínea tras la intervención quirúrgica. Se cuantificarán las primeras 48 horas del postoperatorio. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
First postoperative 48 hours |
Primeras 48h postoperatorias |
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E.5.2 | Secondary end point(s) |
1. Related to bleeding: ? Proportion of patients requiring blood transfusion in the postoperative period ? Units of blood transfused ? Preoperative haemoglobin: for 12 h before surgery ? Postoperative haemoglobin: 24 hours and 5 days . 2. Complications related to surgical wound ? Proportion of patients with wound infection ? Proportion of patients with wound dehiscence ? Proportion of patients in the surgical seroma ? Proportion of patients with re-operation for wound complications ? Patient's postoperative pain (Visual Analogical Scale) 3. Related to drug safety evaluation: 4. Process-related cancer ? Local recurrence rate ? Rate of distant spread ? Survival rate ? Proportion of patients who delayed the start of adjuvant chemotherapy ? Proportion of patients in which delays the onset of postoperative radiotherapy 5. Other variables: ? Incidence of deep vein thrombosis on admission ? Time in hospital ? Mortality |
1. Relacionadas con el sangrado: ? Proporción de pacientes que necesitan transfusión sanguínea en el postoperatorio ? Unidades de sangre transfundidas ? Hemoglobina preoperatoria: durante las 12 h previas a la intervención ? Hemoglobina postoperatoria 24h- 5 días. 2. Relacionadas con complicaciones de la herida quirúrgica: ? Proporción de pacientes con infección de la herida ? Proporción de pacientes con dehiscencia de la herida ? Proporción de pacientes con seroma en el lecho quirúrgico ? Proporción de pacientes con re-operación por complicaciones de la herida ? Dolor postoperatorio del paciente (Escala Visual Analógica) 3. Relacionadas con la seguridad del medicamento evaluado: 4. Relacionadas con el proceso oncológico ? Tasa de recidiva local ? Tasa de diseminación a distancia ? Tasa de supervivencia a un año ? Proporción de pacientes en los que se retrasa el inicio de quimioterapia adyuvante ? Proporción de pacientes en los que se retrasa el inicio de radioterapia postoperatoria 5. Otras variables: ? Incidencia de trombosis venosas profundas durante el ingreso ? Tiempo de estancia hospitalaria ? Mortalidad |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The postoperative days, 3 and 6 weeks after the intervention. |
Los días de ingreso hospitalario, a las 3 y 6 semanas tras la intervención. |
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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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | 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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Hemostasia con electrocoagulación |
Haemostasia with electrocoagulation |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
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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The last visit of the last subject undergoing the trial |
La última visita del último paciente incluido en el estudio |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |