E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Bronchopleural fistula |
Fístula broncopleural |
|
E.1.1.1 | Medical condition in easily understood language |
Bronchopleural fistula |
Fístula broncopleural |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10053481 |
E.1.2 | Term | Bronchopleural fistula |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
|
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 evaluate the efficiency of autologous platelet-poor plasma (PPP) in the prevention of bronchopleural fistula in patients undergoing lung resection. |
Evaluar en pacientes sometidos a cirugía de resección pulmonar la eficacia del plasma autólogo pobre en plaquetas (PPP) en la prevención de la fístula broncopleural. |
|
E.2.2 | Secondary objectives of the trial |
-To reduce the incidence of bronchopleural fistula in patients undergoing pneumonectomy.
-To reduce the incidence of bronchopleural fistula in patients undergoing lobectomy.
-Reduction of morbidity and mortality of patients undergoing lung resection surgery
- To measure the extent of heling and remodeling of the bronchial stump after local application of PPP.
-To decrease the economic cost of patients undergoing lung resection surgery |
-Disminuir la incidencia de fístula broncopleural en pacientes sometidos a neumonectomía.
-Disminuir la incidencia de fístula broncopleural en pacientes sometidos a lobectomía.
-Disminución de la morbi-mortalidad de pacientes sometidos a cirugía de resección pulmonar
- Valorar la capacidad de cicatrización y remodelación del muñón bronquial tras la aplicación local de PPP.
-Disminución del coste económico de los pacientes sometidos a cirugía de resección pulmonar |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Patients over 30 y/o Tumor-free margins in the surgical specimen -Patients who underwent pneumonectomy, lobectomy, or bilobectomy for lung cancer |
-Pacientes mayores de 30 años -Márgenes libres de tumor en la pieza quirúrgica -Pacientes en los que se realiza neumonectomía, lobectomía, o bilobectomía por cáncer de pulmón |
|
E.4 | Principal exclusion criteria |
-There is no upper age limit -Infections prior to surgery (pleural empyema) -Tumor-affected surgical margins |
-No hay exclusión por límite superior de edad -Complicaciones infecciones previas a la cirugía (empiema pleural) -Márgenes quirúrgicos afectos por tumor |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- 22% reduction in the presence of FBP in patients with pneumonectomy and treatment with PPP. - 7.5% decrease in the presence of FBP in patients with lobectomy / bilobectomy and treatment with PPP. - Reduction of morbidity and mortality in patients undergoing lung resection. |
- Disminución del 22% en la presencia de FBP en pacientes con Neumonectomía y tratamiento con PPP. - Disminución del 7.5% de la presencia de FBP en pacientes con Lobectomía / bilobectomía y tratamiento con PPP. - Disminución de la morbi-mortalidad de los pacientes sometidos a resección pulmonar. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of the follow-up (month 6) |
Al final del periodo de seguimiento (mes 6) |
|
E.5.2 | Secondary end point(s) |
- Increased capacity of healing and remodeling of the bronchial stump after local application of PPP. -Decrease the economic cost of patients undergoing lung resection |
- Aumento de la capacidad de cicatrización y de remodelación del muñón bronquial tras la aplicación local de PPP. -Disminución del coste económico de los pacientes sometidos a cirugía de resección pulmonar. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
At the end of the follow-up (month 6) |
Al final del periodo de seguimiento (mes 6) |
|
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 | No |
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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.3 | Single blind | Yes |
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 |
Práctica Clínica Habitual |
Rutinary Treatment |
|
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 | 7 |
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
|
|
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 | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |