[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-chest-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-chest-syndrome":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,73,95,120,145],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100578974","phase-3-efficacy-and-safety-of-tocilizumab-for-acute-chest-syndrome-treatment-in-patients-with-sickle-cell-disease-100578974",false,"NCT06818266","Efficacy and Safety of Tocilizumab for Acute Chest Syndrome Treatment in Patients With Sickle Cell Disease","Efficacy and Safety of Tocilizumab for Acute Chest Syndrome Treatment in Pediatric and Adult Patients With Sickle Cell Disease","TOCIACS","Inclusion Criteria:\n\n1. SCD patient of all genotypes (SS, SC, S\u002Fβ0 and S\u002Fβ+ or other major SCD syndrome)\n2. Age ≥ 2 years old\n3. Hospitalized for ACS, defined by the WHO as the association of fever and\u002For acute respiratory symptoms with a new pulmonary infiltrate on chest imaging, (X-ray, lung ultrasound, or CT scan)\n4. Requiring supplemental oxygen ≥ 2 L\u002Fmin for SpO2 ≥ 95% or non-invasive respiratory support (high flow nasal oxygen or continuous positive airway pressure or bilevel non-invasive ventilation) or invasive mechanical ventilation or ECMO, for less than 48 hours\n5. Negative pregnancy test for girls or women of childbearing age\n6. Freely given, informed and written consent of patient or legal representatives\n7. Affiliation to the social security (or health insurance)\n8. Effective contraception up to 3 months after the administration of treatment (tocilizumab or placebo)\n\nExclusion Criteria:\n\n1. Impossibility to perform tocilizumab\u002Fplacebo injection within the first 48 hours of supplemental oxygen ≥2L\u002Fmin for SpO2≥95% and\u002For respiratory support (as defined in inclusion criteria n°4). If exchange transfusion is indicated at inclusion, it has to be performed before the injection of tocilizumab\u002Fplacebo.\n2. Known hypersensitivity to tocilizumab or its excipients\n3. Known active current severe bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C, and herpes zoster)\n4. Immunization with a live\u002Fattenuated vaccine within the last 4 weeks\n5. Immunomodulatory therapy, anti-rejection therapy, cell depleting therapies and investigational agents within the last 3 months\n6. History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies\n7. History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower gastrointestinal disease such as Crohn's disease, ulcerative colitis, or other symptomatic lower gastrointestinal conditions that might predispose a patient to perforations\n8. Evidence of malignant disease or malignancies diagnosed within the last 3 years\n9. Pregnancy or breastfeeding\n10. Imminent and inevitable progression towards death in the opinion of the investigator\n11. Absolute neutrophil count \\\u003C 1.0 G\u002FL or platelets \\\u003C 50 G\u002FL\n12. ALT or AST \\> 5-fold the upper limit of normal\n13. Glomerular Filtration rate (GFR) \\\u003C 60 mL\u002Fmin\u002F1,73 m²\n14. Current enrolment in another interventional research concerning a medicinal product for human use","ALL","2 Years",{"count":20,"type":21},130,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to determine whether a single infusion of tocilizumab is effective in reducing the time to successful weaning from both supplemental oxygen and any respiratory support, in pediatric and adult patients with sickle cell disease (SCD) during acute chest syndrome (ACS).",[27,28],"Sickle Cell Disease","Acute Chest Syndrome",[30,31,32],"Sickle cell disease","Acute chest syndrome","Tocilizumab","RECRUITING","2026-06-22",{"date":36,"type":37},"2026-06-24","ACTUAL",{"date":39,"type":37},"2025-08-27",{"date":41,"type":21},"2027-07",{"name":43,"class":44},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":45},"100583772","ultrasound-acute-chest-syndrome-sickle-cell-disease-100583772","NCT06880679","Ultrasound Acute Chest Syndrome Sickle Cell Disease","Use of Point-of-Care Ultrasound (POCUS) for the Diagnosis of Acute Chest Syndrome in Patients With Sickle Cell Disease","POCUS","Inclusion Criteria:\n\n1. Age: 0-25 years old\n2. Diagnosis: Patients with a documented diagnosis of sickle cell disease (any genotype)\n3. Disposition: Hospitalized for a SCD-related complication (e.g. VOC)\n\nExclusion Criteria:\n\n1. Patient is considered hemodynamically unstable to undergo consent and study procedures\n2. Already has diagnosis of ACS prior to admission to inpatient unit\n3. POCUS operator not available","25 Years",{"count":56,"type":21},30,[58],"NA","Feasibility and reliability of ultrasound in the inpatient hematology setting.",[28,27],[27,62,28,52,63],"Sickle Cell Anemia","Ultrasound","2026-04-06",{"date":66,"type":37},"2026-04-09",{"date":68,"type":37},"2025-04-08",{"date":70,"type":21},"2026-06-30",{"name":72,"class":44},"Indiana University",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":80,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":45},"100488450","phase-2-tocilizumab-for-acute-chest-syndrome-100488450","NCT05640271","Tocilizumab for Acute Chest Syndrome","Low-Dose Tocilizumab for Acute Chest Syndrome in Sickle Cell Disease","Inclusion Criteria:\n\n* Adults ≥ 12 years of age\n* Prior diagnosis of sickle cell disease (Hb SS, Hb SC, Hb Sb+, and Hb Sb0)\n\nExclusion Criteria:\n\n* Pregnant patients or breastfeeding mothers.\n* Prior treatment with gene therapy or a stem cell transplant.\n* Current enrollment in a clinical trial involving an FDA-regulated drug or biologic.\n* Current neutropenia (absolute neutrophil count \\< 1000\u002Fmm\\^3)\n* Current thrombocytopenia (platelet count \\< 50,000 mm\\^3)\n* Aspartate aminotransferase (AST) or alanine transaminase (ALT) \\> 10 times the upper limit of normal (ULN)\n* History of tuberculosis (TB).\n* Positive purified protein derivative (PPD) TB screening test.\n* On active therapy with a Bruton's tyrosine kinase-targeted agent, which include the following: Acalabrutinib, Ibrutinib, Zanubrutinib\n* On active therapy with a JAK2-targeted agent, which include the following: Baricitinib, Ruxolitinib, Tofacitinib, Upadacitinib\n* Any of the following biologic immunosuppressive agent (and any biosimilar versions thereof) administered in the past 6 months:\n\nAbatacept, Adalimumab, Alemtuzumab, Atezolizumab, Belimumab, Blinatumomab, Brentuximab, Certolizumab, Daratumumab, Durvalumab, Eculizumab, Elotuzumab, Etanercept, Gemtuzumab, Golimumab, Ibritumomab, Infliximab, Inotuzumab, Ipilimumab, Ixekizumab, Moxetumomab, Nivolumab, Obinutuzumab, Ocrelizumab, Ofatumumab, Pembrolizumab, Polatuzumab, Rituximab, Sarilumab, Secukinumab, Tocilizumab, Tositumumab, Tremelimumab, Urelumab, Ustekinumab","12 Years",{"count":82,"type":21},200,[84],"PHASE2","The investigators are evaluating the role of a low dose of tocilizumab in treating acute chest syndrome in patients with sickle cell disease. Tocilizumab inhibits interleukin-6 (IL-6) receptors and is used to treat rheumatoid arthritis and severe cytokine release syndrome, which can be seen with chimeric antigen receptor T-cell (CAR-T) therapy, and it is also authorized for treatment of COVID-19. Since IL-6 levels are elevated in the sputum of patients with acute chest syndrome, the investigators are hopeful that this will be an effective strategy. The investigators will be looking at how a low dose of tocilizumab affects oxygen status, clinical outcomes, and laboratory markers in patients admitted to the hospital with acute chest syndrome.",[27,28],"2026-03-31",{"date":64,"type":37},{"date":90,"type":37},"2023-04-10",{"date":92,"type":21},"2027-01",{"name":94,"class":44},"University of Chicago",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":17,"minAge":102,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":5},"100611875","morphine-clearance-and-glomerular-filtration-in-sickle-cell-patients-in-crisis-in-intensive-care-100611875","NCT07246265","Morphine Clearance and Glomerular Filtration in Sickle Cell Patients in Crisis in Intensive Care","PHEDREA","Inclusion Criteria:\n\n* Patient ≥ 18 years old\n* Known homozygous sickle cell disease SS, SC, S-beta+, or S-beta0\n* Admitted in an intensive care unit\n* Clinical diagnosis of vaso-occlusive crisis and\u002For acute chest syndrome\n* Receiving PCA treatment with morphine\n* Patient's consent for study participation and\u002For from a relative if case of patient's incapacity\n* Affiliation to social protection\n\nExclusion Criteria:\n\n* Patient previously included in the study during a previous stay\n* Injection of iodinated contrast medium outside the scope of the study within 24 hours prior to inclusion, or scheduled within 9 hours following the scheduled time of iohexol injection\n* Contraindication to iohexol: known or suspected immediate or delayed hypersensitivity, thyrotoxicosis.\n* Patient undergoing morphine treatment or substitution treatment such as methadone or buprenorphine prior to hospitalization (having received morphine or a derivative regardless of the route of administration in the week prior to hospitalization).\n* Chronic liver disease likely to interfere with morphine metabolism (cirrhosis )\n* Any condition that contraindicates the use of morphine according to the summary of product characteristics\n* Patients under legal protection\n* Pregnant or breastfeeding women\n\nExclusion criteria :\n\n* Need for extrarenal epuration within 24 hours of inclusion","18 Years",{"count":104,"type":21},100,[58],"Background: Sickle cell disease is a genetic disorder of haemoglobin (which carries oxygen in red blood cells). The shape of sickle cell-patients' red blood cells is abnormal. Thus, red blood cells can be blocked in small vessels, responsible for painful crises due to a lack of downstream circulation. These crisis (acute vaso-occlusive crisis) require strong treatment based on morphine, and often require intensive care.However, treatment is often insufficiently effective. Patient can also experiment acute chest syndrome, a complication of vaso-occlusive crisis, which can be responsible for respiratory failure. In addition, patients with sickle cell disease frequently have kidney damage called sickle cell nephropathy, which in the early stages of the disease is responsible for renal hyperfiltration, meaning that the kidneys filter the blood more than necessary, with faster elimination of drugs. For example, it is known that higher doses of antibiotics must be used in these patients than in the general population for the same effectiveness. The hypothesis of the study is that morphine, a drug eliminated by kidneys, is underdosed in patients with sickle cell disease, which is responsible for the difficulties in achieving sufficient analgesia.\n\nObjective: To determine the glomerular filtration rate threshold for which it is necessary to prescribe higher doses of morphine in sickle cell patients with vaso-occlusive crisis.\n\nMethods: inclusion of 100 patients admitted to intensive care for an acute vaso-occlusive crisis or acute chest syndrome and receiving morphine. Within 24 hours of study inclusion, four morphine dosages will be performed, in parallel with a precise determination of the glomerular filtration rate by measuring the elimination rate of a tracer, 100% eliminated by the kidneys and injected at the start of the study. This tracer is iohexol, a contrast agent commonly used in radiology. Morphine underdosage will be interpretated regarding glomerular filtration rate. The effectiveness of analgesia and the amount of analgesics required will be also be analyzed.\n\nOutlook: At the end of this study, the investigators will be able to offer adapted doses of morphine for sickle cell patients in crisis, adapted to glomerular filtration rate, in the aim of personalizing analgesia.",[27,108,109,110,28],"Glomerular Hyperfiltration","Sickle Cell Nephropathy","Vaso-Occlusive Crises","2026-03-09",{"date":113,"type":37},"2026-03-10",{"date":115,"type":37},"2026-03-05",{"date":117,"type":21},"2028-09",{"name":119,"class":44},"University Hospital, Tours",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":17,"minAge":102,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":131,"conditions":132,"keywords":133,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":45},"100569736","awake-prone-positioning-for-severe-acute-chest-syndrome-100569736","NCT06698120","Awake Prone Positioning for Severe Acute Chest Syndrome","Assessment of Efficacy and Safety of Awake Prone Positioning in Sickle Cell Anemia Patient Admitted in Intensive Care Unit for Severe Acute Chest Syndrome","PRONE-ACS","Inclusion Criteria:\n\n* Age \\>18 years\n* Major sickle cell anemia (SS, SC, Sβ)\n* Admission in intensive care unit for ACS\n* Registered in the French social insurance regime.\n* Written, informed consent\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Immediate need for intubation\n* Impaired vigilance status (Glasgow scale score \\\u003C 12)\n* Pneumothorax\n* Haemodynamically unstable\n* Thoracic trauma admission\n* Severely obese with body-mass index higher than 40 kg\u002Fm²\n* EIT contraindication: pacemaker, automatic implantable defibrillators, skin lesions facing the EIT belt, unstable rachis fracture or medullary lesions",{"count":129,"type":21},15,[58],"Acute chest syndrome (ACS) is the leading cause of admission to intensive care and the leading cause of death in patients with sickle cell disease. Irrespective of the cause of ACS, there is an heterogeneity in pulmonary ventilation\u002Fperfusion ratios, leading to worsening of the disease.\n\nEfficiency of awake prone positioning (APP) in acute respiratory failure (ARF) was particularly highlighted during the COVID-19 pandemic. Several physiological factors contribute to this benefit including an improvement in ventilatory drive and gas exchange.\n\nThe investigator hypothesize that APP could lead to clinical improvement in ACS in terms of oxygenation and ventilatory drive, by improving the heterogeneity of ventilation",[28,62],[28,62,134,135],"Awake Prone Positioning","Electric Impedance","NOT_YET_RECRUITING","2025-08-25",{"date":139,"type":37},"2025-09-02",{"date":141,"type":21},"2026-01",{"date":143,"type":21},"2027-08",{"name":43,"class":44},{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":17,"minAge":102,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":155,"conditions":156,"keywords":157,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":45},"100532595","early-goal-directed-automated-red-blood-cell-exchange-for-acute-chest-syndrome-in-sickle-cell-disease-100532595","NCT06214845","Early-goal Directed Automated Red Blood Cell Exchange for Acute Chest Syndrome in Sickle Cell Disease","Early-goal Directed Automated Red Blood Cell Exchange for Acute Chest Syndrome in Sickle Cell Disease: a Multicentre, Randomised, Clinical Trial","ARCAD","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patient with major sickle cell disease syndrome (SS, SC, Sβ0 or Sβ+)\n* ACS, as defined by the association of fever and\u002For acute respiratory symptoms with a new pulmonary infiltrate on chest imaging\n* Requiring supplemental oxygen ≥ 2 L\u002Fmin for SpO2 ≥ 95%\n* With an indication for REX given the hypoxemic ACS, as per recommendations\n* Express informed consent from the relatives or the patient himself, or emergency inclusion procedure in case of inability of patient or proxy relatives to give consent NB: Patients not affiliated to social security will be included in the study given the precarious social situation of many patients with SCD\n\nExclusion Criteria:\n\n* Patient having both ACS criteria and need for supplemental oxygen ≥ 2 L\u002Fmin for SpO2 ≥ 95% since more than 72 hours\n* Red blood cell transfusion or REX during the current ACS episode\n* Any past medical history of delayed haemolytic transfusion reaction\n* History of \\\u003C 12 transfused RBC or anti-red blood cell antibody production on the one hand and no possibility for matching on Rh\u002FK, antibody specificity, and extended to Duffy (Fya), Kidd (Jka and Jkb) and MNS (M, N, S and s) phenotypes on the other hand (12)\n* Known legal incapacity (guardianship, curatorship)\n* Prisoners or subjects who are involuntarily incarcerated\n* Anatomical factors precluding placement of an adequate venous access\n* Known pregnancy or current lactation",{"count":20,"type":21},[58],"Sickle cell disease (SCD) is characterized by recurrent vaso-occlusive pain crisis (VOC), which may evolve to acute chest syndrome (ACS), the most common cause of death among adult patients with SCD. Currently, there is no etiologic treatment to abort ACS. Therefore, management of ACS mostly involve a symptomatic approach including in routine, and as per recommendations, hydration, analgesics, supplemental oxygen, and transfusion.\n\nThe polymerisation of sickle haemoglobin (HbS) is one major feature in the pathogenesis of vaso-occlusion. Current guidelines recommend red blood cell exchange transfusion (REX) in patients with severe ACS in order to improve oxygenation and reduce HbS concentration to blunt sickling. REX is often preferred over simple transfusion in this setting because it rapidly reduces HbS without raising final haematocrit. There are currently two methods for REX: manual (with sequential phlebotomies and transfusions) or automated (erythrocytapheresis). The former allows a sober use of red blood cell packs, while the latter achieves haematological targets (HbS and haematocrit) quickly and more consistently, but requires a special equipment and trained staff. As a result of inflammation and intravascular hemolysis, the plasma of patients with ACS may also contain several components that promote vaso-occlusion, lung injury and organ failure, including cytokines (e.g., IL-6), free haemoglobin and free haem. Conversely, it is depleted in haptoglobin and hemopexin, which normally bind to and clear cell-free haemoglobin. The addition of therapeutic plasma exchange to erythrocytapheresis during automated REX may therefore have a dual beneficial effect in patients with overt intravascular hemolysis: i) deplete the inflammatory mediators and products of hemolysis; ii) replete haptoglobin and hemopexin. REX modalities (automated vs manual) have not been tested during ACS.\n\nThe hypothesis is that early-goal directed automated REX may accelerate the resolution of severe ACS as compared to manual REX.",[28],[158,159,160,161,162],"Sickle cell disease (SCD)","Acute chest syndrome (ACS)","Red blood cell exchange (REX)","Oxygen","Respiratory support","2024-01-17",{"date":165,"type":37},"2024-01-22",{"date":167,"type":21},"2024-03-01",{"date":169,"type":21},"2026-09-01",{"name":43,"class":44}]