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| Name | Class |
|---|---|
| Orion Corporation, Orion Pharma | INDUSTRY |
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Xenon is a gaseous anaesthetic agent registered in several European countries. It has been administered safely during cardiac surgery in pilot studies. In animal studies, xenon decreases the size of experimental myocardial infarction.
This 3-arm study will compare xenon, sevoflurane and a propofol-based total intravenous anaesthesia for maintenance of anaesthesia during coronary artery bypass graft surgery conducted with extra-corporeal circulation. Xenon and sevoflurane will be administered before and after extracorporeal circulation. Propofol will be administered during extracorporeal circulation in the three groups of patients.
The study will compare the postoperative myocardial damage observed 24 hours after surgery from blood levels of troponin I, a largely accepted biomarker of myocardial necrosis. The main hypothesis is that the myocardial damage observed after xenon administration will not be superior to the damage observed after sevoflurane administration (non-inferiority). The second hypothesis is that the myocardial damage observed after xenon administration will be inferior to the damage observed after total intravenous anaesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xenon | Experimental |
| |
| Sevoflurane | Active Comparator |
| |
| Total intravenous anaesthesia | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenon | Drug | Inhaled xenon, maximal inspired concentration of 65%. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Level of Troponin I | Blood level of troponin I measured by a central laboratory | Sampling performed 24 hours after the end of the surgical procedure |
| Log-transformed Blood Level of Troponin I | Blood level of troponin I measured by a central laboratory | Sampling performed 24 hours after the end of the surgical procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Depth of Anaesthesia | On-line monitoring of depth of anaesthesia from bi-spectral electroencephalogram analysis (BIS monitor) | 4 hours |
| Arterial Oxygen Saturation | Arterial blood gases |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan HOFLAND, MD, PhD | Thorax Centre Erasmus MC, Rotterdam, the Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Cardiovasculaire et Pneumologique Louis Pradel | Bron | 69677 | France | |||
| CHU de Caen |
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A total of 542 patients were enrolled (509 met the inclusion criteria) from 17 centres in 4 countries; 8 sites in France, 6 sites in Germany, 1 site in Italy and 2 sites in The Netherlands.
Date of first enrolment: 20 April 2011 Date of last completed: 05 April 2014
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| ID | Title | Description |
|---|---|---|
| FG000 | Xenon Including Pilot Patients | Anesthetic agent before and after CPB: xenon |
| FG001 | Sevoflurane | Anesthetic agent before and after CPB: sevoflurane |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Sevoflurane |
| Drug |
Inhaled sevoflurane, maximal inspired concentration of 1.8%. |
|
| Propofol | Drug | Hourly dose of 2-4 mg/kg |
|
| 4 hours |
| Haemodynamic Profile | Monitoring of heart rate, arterial blood pressure, central venous pressure. | 4 hours |
| Presence or Absence of Postoperative Delirium | Confusion Assessment Method | 7 days |
| Clinical Laboratory Tests | 7 days |
| ECG Abnormalities | 7 days |
| Vital Signs | 7 days |
| Presence of Absence of Adverse Events, Including Myocardial Infarction | 7 days |
| Caen |
| 14033 |
| France |
| Hôpital G&R Laennec - Centre Hospitalier Universitaire de Nantes | Nantes | 44093 | France |
| Centre Hospitalo-Universitaire Pitié-Salpetrière | Paris | 75013 | France |
| Hôpital du Haut-Lévêque | Pessac | 33600 | France |
| Hôpital Pontchaillou | Rennes | 35033 | France |
| Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil | Strasbourg | 67091 | France |
| Centre Hospitalier de Rangueil | Toulouse | 31059 | France |
| Universitätsklinikum Schleswig-Holstein | Kiel | Schleswig-Holstein | 24105 | Germany |
| University Hospital Aachen | Aachen | 52074 | Germany |
| Klinikum Links der Weser - Senator-Wessling-Str. 1 | Bremen | 28277 | Germany |
| University Hospital Frankfurt AM Main | Frankfurt | 60590 | Germany |
| UniversitatsKlinikum Schleswig-Holstein | Lübeck | 23538 | Germany |
| University Hospital ROSTOCK | Rostock | 18057 | Germany |
| Policlinico Umberto I | Rome | 00161 | Italy |
| Academic Medical Center - University of Amsterdam | Amsterdam | 1100 DD | Netherlands |
| Thorax Center - Erasmus MC | Rotterdam | 3000 CA | Netherlands |
| FG002 | TIVA | Anesthetic agent before and after CPB: propofol |
| COMPLETED |
|
| NOT COMPLETED |
|
Full Analysis Set (FAS): randomised and treated patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Xenon | Anesthetic agent before and after CPB: xenon |
| BG001 | Sevoflurane | Anesthetic agent before and after CPB: sevoflurane |
| BG002 | TIVA | Anesthetic agent before and after CPB: propofol |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m² |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Level of Troponin I | Blood level of troponin I measured by a central laboratory | The primary analysis was a non-inferiority comparison between Xenon and Sevoflurane and was performed on the Per Protocol (PP) Set composed of all randomised and treated patients with no major protocol deviations during the study. | Posted | Least Squares Mean | 95% Confidence Interval | ng/mL | Sampling performed 24 hours after the end of the surgical procedure |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Depth of Anaesthesia | On-line monitoring of depth of anaesthesia from bi-spectral electroencephalogram analysis (BIS monitor) | Not Posted | 4 hours | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Arterial Oxygen Saturation | Arterial blood gases | Not Posted | 4 hours | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Haemodynamic Profile | Monitoring of heart rate, arterial blood pressure, central venous pressure. | Not Posted | 4 hours | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Presence or Absence of Postoperative Delirium | Confusion Assessment Method | Not Posted | 7 days | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Laboratory Tests | Not Posted | 7 days | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ECG Abnormalities | Not Posted | 7 days | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Vital Signs | Not Posted | 7 days | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Presence of Absence of Adverse Events, Including Myocardial Infarction | Not Posted | 7 days | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Log-transformed Blood Level of Troponin I | Blood level of troponin I measured by a central laboratory | The non-inferiority comparison between Xenon and Sevoflurane was repeated using log-transformed blood troponin levels on the PP Set. | Posted | Least Squares Mean | 95% Confidence Interval | ng/mL | Sampling performed 24 hours after the end of the surgical procedure |
|
|
Adverse Events observed from the start of study treatment up to 30 days.
Participants at risk are the patients from the safety set
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Xenon Including Pilot Patients | Anesthetic agent before and after CPB: xenon | 30 | 178 | 154 | 178 | ||
| EG001 | Sevoflurane | Anesthetic agent before and after CPB: sevoflurane | 24 | 165 | 139 | 165 | ||
| EG002 | TIVA | Anesthetic agent before and after CPB: propofol | 26 | 166 | 143 | 166 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CARDIAC TAMPONADE | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CARDIOGENIC SHOCK | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CARDIOVASCULAR INSUFFICIENCY | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| LOW CARDIAC OUTPUT SYNDROME | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ARTERIOSPASM CORONARY | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| VENTRICULAR FIBRILLATION | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| BRONCHIAL FISTULA | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HAEMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| BRONCHOSPASM | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| MEDIASTINITIS | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| PNEUMONIA HAEMOPHILUS | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| PNEUMONIA STAPHYLOCOCCAL | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| BRONCHITIS HAEMOPHILUS | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| OPERATIVE HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| SURGICAL SKIN TEAR | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| VASCULAR GRAFT OCCLUSION | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| POST PROCEDURAL MYOCARDIAL INFARCTION | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| POSTOPERATIVE THORACIC PROCEDURE COMPLICATION | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| FEMORAL ARTERY OCCLUSION | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| SHOCK HAEMORRHAGIC | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HAEMORRHAGE | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| AIR EMBOLISM | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HAEMODYNAMIC INSTABILITY | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CONVULSION | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| COMA | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HEMIPARESIS | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| MULTI-ORGAN FAILURE | General disorders | MedDRA (14.0) | Systematic Assessment | General disorders and administration site conditions |
|
| HYPERTHERMIA | General disorders | MedDRA (14.0) | Systematic Assessment | General disorders and administration site conditions |
|
| IMPAIRED HEALING | General disorders | MedDRA (14.0) | Systematic Assessment | General disorders and administration site conditions |
|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HAEMORRHAGIC ANAEMIA | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| INTESTINAL ISCHAEMIA | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| TROPONIN I INCREASED | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| TROPONIN INCREASED | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| AGITATION | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HEPATIC ISCHAEMIA | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| COMPARTMENT SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Electrocardiogram ST Segment Elevation | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Troponin T increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Bispectral index decreased | Investigations | MedDRA (14.0) | Systematic Assessment | Bispectral index considered unexpectedly low for one investigator |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Insomnia | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jan HOFLAND | Radboudumc, Department of Anaesthesiology | +31243611111 | 3658 | Jan.Hofland@radboudumc.nl |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
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| ID | Term |
|---|---|
| D014978 | Xenon |
| D000077149 | Sevoflurane |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D005741 | Noble Gases |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
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| Male |
|
| Italy |
|
| France |
|
| Germany |
|
|
|