[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100369848":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":37,"locations":48,"responsibleParty":101,"collaborators":105,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":113,"sex":119,"minAge":120,"maxAge":26,"enrollmentInfo":121,"targetDuration":26,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":26,"overallStatus":50,"whyStopped":26,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Aarhus University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"VATS \u002F surgical group","EXPERIMENTAL","The VATS procedure must be completed as soon as possible and no later than 48 hours after randomisation. The surgery is performed with the patient in a 90 degree sideways position, using general anesthesia. Access is obtained through one to three ports, followed by purification and possibly decortication, and insertion of one pleural drain (sizes 24 - 32F) at the end of surgery. 20 ml Marcain is used as local analgetic and applied at the incision sites or as a nerve block. In the VATS group, suction on drain (- 15 cm H20) is applied in the first day after the procedure. Operator must have relevant training and competencies corresponding to the specialist level within the relevant specialty and be registered and approved by the steering committee.",[13],"Procedure: VATS group",{"label":15,"type":16,"description":17,"interventionNames":18},"Drain and intrapleural therapy group","ACTIVE_COMPARATOR","Pigtail is applied as soon as possible and within 48 hours after randomisation. Drain placement is carried out using ULS. Operators (conductors of the procedure) must have relevant training and competencies corresponding to the specialist level within the relevant specialty and be approved by the steering committee to conduct the procedure. A pigtail catheter (minimum 10F) is inserted. Operator determines the size of drain and whether drain placement is done with one-step or Seldinger technic.\n\nThe intrapleural therapy consists of treatment with the following two drugs:\n\n* intrapleural Actilyse® (alteplase) 10 mg twice daily for three days\n* intrapleural Pulmozyme® (DNase) 5 mg twice daily for three days",[19],"Procedure: Drain and intrapleural therapy group",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","VATS group","VATS procedure with drainage, including rinse with NaCl",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Drainage with pigtail and Intrapleural therapy",[15],[31,35],{"name":32,"affiliation":33,"role":34},"Christian B Laursen, MD, PhD","Odense University Hospital","PRINCIPAL_INVESTIGATOR",{"name":32,"affiliation":36,"role":34},"Department of Respiratory Medicine, Odense University Hospital, Odense, Denmark",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Thomas D Christensen, MD, PhD","CONTACT","24778857","45","tdc@clin.au.dk",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Morten Bendixen, MD, PhD","24778895","pinseferie@gmail.com",[49,70,84],{"facility":5,"status":50,"city":51,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Aarhus","8200","Denmark","DK",{"type":56,"coordinates":57},"Point",[58,59],10.21076,56.15674,{"lat":59,"lon":58},[62,65,67,68],{"name":39,"role":40,"phone":63,"phoneExt":64,"email":43},"29418528","+45",{"name":45,"role":40,"phone":66,"phoneExt":64,"email":47},"61188976",{"name":39,"role":34,"phone":26,"phoneExt":26,"email":26},{"name":69,"role":34,"phone":26,"phoneExt":26,"email":26},"Thomas D Christensen, MD",{"facility":71,"status":72,"city":73,"state":26,"zip":26,"country":53,"countryCode":54,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Rigshospitalet","NOT_YET_RECRUITING","Copenhagen",{"type":56,"coordinates":75},[76,77],12.56553,55.67594,{"lat":77,"lon":76},[80,83],{"name":81,"role":40,"phone":26,"phoneExt":26,"email":82},"Merete Christensen, MD","Merete.Christensen.02@regionh.dk",{"name":81,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":33,"status":50,"city":85,"state":26,"zip":26,"country":53,"countryCode":54,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Odense",{"type":56,"coordinates":87},[88,89],10.38831,55.39594,{"lat":89,"lon":88},[92,95,99],{"name":93,"role":40,"phone":26,"phoneExt":26,"email":94},"Peter B Licht, MD, PhD","peter.licht@rsyd.dk",{"name":96,"role":40,"phone":97,"phoneExt":64,"email":98},"Christian","40383944","christian.b.laursen@rsyd.dk",{"name":100,"role":34,"phone":26,"phoneExt":26,"email":26},"Peter Licht, MD, PhD",{"type":102,"investigatorFullName":103,"investigatorTitle":104,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Thomas Decker Christensen","Consultant, Professor, MD, DMSc., Ph.D",[106,107,109],{"name":33,"class":6},{"name":108,"class":6},"Rigshospitalet, Denmark",{"name":110,"class":6},"Aalborg University Hospital","100369848","vats-surgery-compared-to-drainage-in-the-treatment-of-pleural-empyema-100369848",false,"NCT04095676","VATS Surgery Compared to Drainage in the Treatment of Pleural Empyema","Intrapleural Fibrinolysis and DNase Versus VATS for the Treatment of Pleural Empyema: a Randomized, Controlled Trial","FIVERVATS","Inclusion Criteria:\n\n* 18 years or more on the day of hospitalization\n* Must be able to provide informed consent\n* Acute hospitalization within the last 48 hours\n* Meeting diagnostic criteria for community acquired pleural infection using the following criteria:\n\n  1. A clinical presentation compatible with pleural infection AND\n  2. Has pleural fluid which is either:\n\n     1. purulent pleural fluid or\n     2. gram stain positive or\n     3. culture positive or\n     4. acidic with pH \\\u003C 7.2 or\n     5. low pleural fluid glucose (\\\u003C 2 mmol\u002FL) in the absence of accurate pH measurement or\n     6. septated pleural fluid on ultrasound\n\nExclusion Criteria:\n\n* • Pregnancy. Prior to inclusion of fertile women (defined as the period from menarche to postmenopause) a negative pregnancy test must be available\n* Breastfeeding\n* Declared terminally ill or a predicted survival of less than 3 months\n* Previous intrathoracic surgery (within \\\u003C1 year on the same side of the thorax as where the parapneumonic effusion\u002Fpleural empyema is located\n* Previously (within \\\u003C1 year) hospitalized with with complex parapneumonic effusion (stage II) or pleural empyema (stage III)\n* Drainage during the current admission on the same side of the thorax (excluding diagnostic pleural puncture)\n* Hospitalization within 7 days prior to current hospitalization\n* Previous allergic reaction to alteplase or DNase\n* Use of alteplase therapy contraindicated:\n\n  * Ongoing treatment with oral anticoagulant incl. new oral anticoagulants (e.g. warfarin (Marevan), Dabigatranetexilat (Pradaxa), Rivaroxaban (Xarelto), Apixaban (Eliquis), Endoxaban (Lixiana))\n  * Significant ongoing bleeding or within last six months\n  * Known haemorrhagic diathesis\n  * Previous or suspected intracranial hemorrhage\n  * Suspected subarachnoidal hemorrhage or condition following subarachnoidal hemorrhage from aneurysm\n  * All forms of damage to the central nervous system (e.g. cerebral tumors, aneurysm, intracranial \u002F spinal surgery)\n  * Recent (within 10 days) cardiac resuscitation, birth, or perforation of non-compressible blood vessel (e.g. puncture of v. subclavia, v. jugularis)\n  * Severe, uncontrolled arterial hypertension\n  * Bacterial endocarditis, pericarditis\n  * Acute pancreatitis\n  * Documented ulcerative gastrointestinal disease within last 3 months, esophagal varices, arterial aneurysm, arterio-venous malformations\n  * Tumor \u002F malignancy with an increased risk of hemorrhage\n  * Severe liver disease, including liver failure cirrhosis, portal hypertension (esophagal varices), and active hepatitis\n  * Large operation or significant trauma within previous 3 months","ALL","18 Years",{"count":122,"type":123},184,"ESTIMATED","INTERVENTIONAL",[126],"NA","Pleura empyema is a frequent disease with a high morbidity and a mortality rate of approximately 15%.\n\nPleura empyema is characterized by the passage of three stages (I - III). The aim of treating the disease is to remove the infection and provide fully expansion of the lung.\n\nThe initial treatment at the early stage of the disease (stage I) is simple drainage. In clinical practice, stages II and III are treated alike.\n\nCurrent standard treatment for these stages is drainage with ultrasound (ULS) -guided pigtail. Simultaneously with drainage, an intrapleural fibrinolyticum can be given. A potential better alternative is surgery in terms of Video Assisted Thoracoscopic Surgery (VATS). The theoretical advantage of early surgery is that patients undergo rapid, definitive treatment. Furthermore, surgery can ensure optimal drain placement. How best to treat these patients (drainage or surgery) is still under clinical evaluation and depends to a great extent on local clinical practice. It is only to a limited extent based on scientific evidence.\n\nThe aim of this study is to determine if there is a difference in outcome in patients diagnosed with stage II and stage III empyema who either receive primary VATS surgery or ULS guided drainage and intrapleural therapy (fibrinolytic (altaplasm) with DNase (Pulmozyne ®)) The primary outcome is Hospitalization time and secondary outcomes is e.g. mortality, health related costs and quality of life.\n\nThe present study can thus provide new and highly relevant knowledge as well as change the treatment of these patients, both nationally and internationally.\n\nIt is planned that a total of 184 patients will be included in the project. The study takes place as a collaboration between all four thoracic surgical departments and the major pulmonary medicine departments in Denmark. In addition, the study has international collaborators\u002Fconsultants who will provide counselling in connection with the study.",[129],"Pleural Empyema","2025-09-30",{"date":132,"type":133},"2025-10-03","ACTUAL",{"date":135,"type":133},"2022-10-30",{"date":137,"type":123},"2028-10-30",{"name":103,"class":6},3]