[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583965":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":25,"responsibleParty":41,"collaborators":25,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":25,"enrollmentInfo":55,"targetDuration":25,"studyType":58,"phases":59,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":68,"whyStopped":25,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":25},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"talc pleurodesis","EXPERIMENTAL","intrapleural instillation of talc slurry",[13],"Drug: talc powder",{"label":15,"type":16,"description":17,"interventionNames":18},"Autolougs blood patch therapy (ABPT)","ACTIVE_COMPARATOR","intrapleural instillation of patient's venous blood",[19],"Biological: patient's own venous blood",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DRUG","talc powder",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"BIOLOGICAL","patient's own venous blood","intrapleural instillation of patient's own venous blood",[15],[32],{"name":33,"affiliation":5,"role":34},"David SC Hui, MD","STUDY_DIRECTOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Ka Pang Chan, MBChB","CONTACT","+852 3505 2211","chankapang@cuhk.edu.hk",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Ka Pang Chan","Assistant Professor","100583965","phase-2-stop-air-leak-by-talc-or-autologous-blood-patch-therapy-100583965",false,"NCT06883188","Stop Air Leak by Talc or Autologous Blood Patch Therapy","A Pilot Randomised Study Comparing the Clinical Efficacy of Stopping Air Leak by Talc Pleurodesis or Autologous Blood Patch Therapy in Secondary Spontaneous Pneumothorax","STOP","Inclusion Criteria:\n\n* Age 18 years or older\n* Radiographically proven pneumothorax and underlying lung disease (either pre-existing or shown in diagnostic imaging at presentation)\n* Spontaneous onset of pneumothorax, not related to trauma or iatrogenic procedure\n* SSP with air leak persists for ≥3 days after the first radiographic evidence of pneumothorax\n* Intend to administer talc or autologous blood patch therapy (ABPT) to stop the air leak as the next step of treatment\n\nExclusion Criteria:\n\n* A chest drain size smaller than Fr 12\n* Bilateral pneumothorax\n* Impaired blood clotting, including baseline INR \\> 1.5, platelet \\\u003C 150 x 10\\^9\u002FL, use of therapeutic dose anticoagulant or dual-antiplatelet agents\n* Active or recent (within 6 weeks) pleural infection\n* Septicaemia or active extrapleural infection (e.g. pneumonia)\n* Use of long-term systemic corticosteroids or immunosuppressant\n* Previously received talc or ABPT to the ipsilateral pleural space for the current episode of pneumothorax\n* Known sensitivity to talc\n* Has had a previous pneumonectomy (either on the same or contralateral side)\n* Patients who are pregnant or lactating (females of childbearing potential must have a negative pregnancy test before randomisation)\n* Expected survival of less than three months from a different pathology to this pneumothorax (e.g. metastatic malignancy)\n* Cognitively impaired and physically unable to follow the turning procedure during intrapleural procedure, or at risk of self-removing chest drain\n* Inability to give informed consent","ALL","18 Years",{"count":56,"type":57},30,"ESTIMATED","INTERVENTIONAL",[60,61],"PHASE2","PHASE3","Objectives: To compare the therapeutic efficacy and safety profiles of intrapleural talc pleurodesis versus autologous blood patch therapy(ABPT) in patients with secondary spontaneous pneumothorax(SSP) complicated by persistent air leak(PAL), and to assess the trial feasibility for a subsequent full-scale, multicentre randomised controlled trial(RCT).\n\nHypothesis: Talc pleurodesis and ABPT demonstrate comparable efficacy in stopping PAL and facilitating chest drain removal within 5 days.\n\nDesign and subjects: This single-centre, two-arm, open-label pilot RCT will recruit 30 patients with SSP and PAL persisting ≥5 days. Eligible patients will be randomised in a 1:1 ratio to receive intrapleural talc pleurodesis or ABPT. Digital chest drain systems will continuously record air leak rates from 24 hours before randomization until 120 hours post-intervention, ensuring objective, real-time data capture. Patients will be followed till 90 days post-discharge.\n\nInterventions: Recruited subjects with PAL ≥5 days will be randomized in 1:1 ratio to receive talc pleurodesis or ABPT.\n\nMain outcome measures: The primary outcome is complete cessation of air leak and successful chest drain removal within 5 days after the intervention. Secondary outcomes include absolute and percentage changes in digitally measured air leak rates, duration of chest drainage, recurrence of ipsilateral pneumothorax, need for additional pleural interventions, and safety outcomes such as drain blockage and pleural infection.\n\nData analysis and expected results: Data will be analysed on an intention-to-treat basis for all randomised subjects with regression models adjusting for confounders. The pilot outcomes will inform sample size calculations and refine design parameters for the proposed full-scale multicentre RCT.",[64],"Pneumothorax Spontaneous Secondary",[66,9,67],"Persistent air leak","autologous blood patch therapy","NOT_YET_RECRUITING","2025-03-12",{"date":71,"type":72},"2025-03-19","ACTUAL",{"date":74,"type":57},"2026-04-01",{"date":76,"type":57},"2029-03-31",{"name":5,"class":6}]