[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vaso-occlusive-crises\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vaso-occlusive-crises":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,69,98],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100631256","phase-3-evaluation-of-the-efficacy-of-iloprost-in-the-management-of-vaso-occlusive-crises-in-adult-patients-with-sickle-cell-disease-100631256",false,"NCT07498309","Evaluation of the Efficacy of Iloprost in the Management of Vaso-occlusive Crises in Adult Patients With Sickle Cell Disease","Evaluation of the Efficacy of Iloprost in the Management of Vaso-occlusive Crises in Adult Patients With Sickle Cell Disease: Multicenter, Randomized, Double-blind, Placebo-controlled Study","PROSTASICKLE","Inclusion Criteria:\n\nPatients with major sickle cell syndrome (all genotypes). 2. Age ≥18 years 3. Require hospitalization and IV opioids for VOC treatment. 4. Admitted less than 36 hours before inclusion; H0 = hospital admission time. 5. Have read and signed informed consent. 6. For women:\n\n* Of childbearing potential (defined by the CTCG as a fertile woman, after menarche and until menopause, except in cases of permanent sterility, including hysterectomy, bilateral salpingectomy, or bilateral oophorectomy);\n\n  * Using a highly effective method of contraception according to CTCG recommendations (combined hormonal contraception \\[containing estrogens and progestogens\\] associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, sexual abstinence) for at least 4 weeks prior to inclusion and throughout the entire duration of systemic exposure to the study treatment. AND\n  * Having a negative urine pregnancy test at inclusion;\n* Postmenopausal: Menopause, according to CTCG recommendations, is defined as the absence of menstruation for 12 months without any other medical cause. Elevated follicle-stimulating hormone (FSH) levels in the postmenopausal interval can be used to confirm postmenopausal status in women who are not using hormonal contraception or hormone replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n\n  7\\. Affiliated with a social security system\n\nExclusion Criteria:\n\n1. Patients with a contraindication to iloprost (ILOPROST ZENTIVA 100 micrograms\u002FmL, solution for dilution for infusion):\n\n   1. pregnancy, breastfeeding\n   2. Hypersensitivity to the active substance or to any of the excipients.\n   3. Conditions where the risk of bleeding may be increased due to the effects of iloprost on platelets (e.g., active peptic ulcer, trauma, intracranial hemorrhage).\n   4. severe coronary disease\n   5. recent MI \\\u003C6 months\n   6. heart failure NYHA II-IV\n   7. severe arrhythmias\n   8. suspicion of pulmonary congestion\n2. Active smoking\n3. Patient presenting with hepatic impairment or renal impairment requiring dialysis\n4. Patient presenting with a contraindication to 5% glucose (Glucose 5%\n\n   FRESENIUS KABI France solution for infusion):\n   1. Hypersensitivity to corn\n   2. Uncontrolled hyperglycemia,\n   3. Decompensated diabetes,\n   4. Other known glucose intolerances (e.g. situations of metabolic stress, acute shock states, collapse),\n   5. Hyperosmolar coma,\n   6. Hyperlactatemia,\n   7. Metabolic acidosis,\n   8. Fluid overload. The administration of high volumes may in particular result, due to fluid overload, in the following contraindications:\n   9. Hyperhydration\n   10. Acute heart failure\n   11. Pulmonary edema\n5. Hypersensitivity to 5% glucose\n6. Severe malnutrition\n7. Thiamine deficiency in chronic alcoholic patients\n8. Patient presenting with arterial hypotension\n9. Patient having experienced a cerebrovascular event within the last 3 months\n10. History of documented opioid dependence\n11. Individuals deprived of liberty or under legal protection.\n12. Patient included in PROSTASICKLE within last 90 days.\n13. Participation in another drug trial within previous month.","ALL","18 Years",{"count":20,"type":21},144,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Sickle cell disease is a severe monogenic genetic disorder caused by an autosomal recessive mutation of the β-globin gene, leading to production of abnormal hemoglobin (HbS). It primarily affects individuals from Africa or the French overseas territories. In France, approximately 26,000 patients are affected. Improved care has significantly increased life expectancy.\n\nVaso-occlusive crises (VOC) are the main clinical complication. They result from polymerization of HbS, deforming red blood cells and causing capillary occlusion, tissue hypoxia, intense bone pain, and frequent hospitalizations. In France in 2015, 25,150 hospitalizations were recorded, 61% of which were for VOC.\n\nIloprost is a prostacyclin (PGI2) analogue with vasodilatory, anti-platelet, anti-inflammatory, and antioxidant properties. It is used to treat severe limb ischemia and Raynaud's phenomenon, administered by IV infusion for 5 to 28 days.\n\nIt is well tolerated and has shown efficacy for bone pain related to bone marrow edema. Its rapid and sustained action makes it an interesting candidate for VOC, which are comparable to ischemic-origin pain. To date, only one reported case of iloprost use for a VOC exists, showing rapid and lasting improvement.\n\nThis randomized, multicenter, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of iloprost in patients hospitalized for VOC, with the objective of reducing pain and opioid consumption.\n\nThis comprehensive approach could significantly improve VOC management.",[27,28],"Vaso-Occlusive Crises","Sickle Cell Disease","NOT_YET_RECRUITING","2026-03-23",{"date":32,"type":33},"2026-03-27","ACTUAL",{"date":35,"type":21},"2026-09",{"date":37,"type":21},"2030-03",{"name":39,"class":40},"University Hospital, Rouen","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"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",{"count":50,"type":21},100,[52],"NA","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.",[28,55,56,27,57],"Glomerular Hyperfiltration","Sickle Cell Nephropathy","Acute Chest Syndrome","RECRUITING","2026-03-09",{"date":61,"type":33},"2026-03-10",{"date":63,"type":33},"2026-03-05",{"date":65,"type":21},"2028-09",{"name":67,"class":40},"University Hospital, Tours",6,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":41},"100621315","phase-2-sub-dissociative-dose-ketamine-in-treatment-of-vaso-occlusive-pain-event-in-children-and-young-adults-100621315","NCT07369024","Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults","Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults: A Randomized Control Trial","Inclusion Criteria:\n\n* Between the ages 5-20 years\n* Diagnosed sickle cell disease. Homozygous (HbSS) or heterozygous (HbSC, HbSBetaThal Plus or Zero) will be included.\n* Presenting with VOE pain, requiring IV pain medication.\n* First dose of analgesic medication is given before patient approached for participation in the study.\n* Primary language is English or Spanish\n* Adult individual or parent\u002Flegal guardian is able and willing to provide informed consent. For individuals 7 to 17 years of age, assent must also be provided when cognitively possible.\n\nExclusion Criteria:\n\n* Sickle cell trait only\n* Patients whose primary language is other than English or Spanish\n* Pain attributed to causes other than VOE\n* Not requiring IV for pain treatment\n* No analgesic (e.g. opiate) is given before approach for study participation due to any reason, including problem with IV access.\n* Oxygen saturation \\\u003C 90% on room air\n* History of prior adverse reaction to ketamine\n* History of hypertension - Patients with active\u002Funcontrolled hypertension defined as systolic 140 mmHg over diastolic of 90 mmHg will be excluded from participation in the study. If hypertension is controlled and at the time of enrollment, systolic and diastolic thresholds of 140 mmHg and 90 mmHg respectively are not exceeded, patient may be included in the study\n* History of significant or uncontrolled cardiovascular disease, liver disease, kidney disease, and thyroid disease\n* Patients with evidence of increased intracranial pressure\n* Patients with elevated intraocular pressure\n* Patients with acute mania or history of bipolar disorder with manic episodes, history of hallucinations or paranoia secondary to previously diagnosed psychiatric condition\n* Pregnant or potentially pregnant patients per patient report. All patients of childbearing potential will undergo pregnancy testing prior to enrollment (as part of clinical care), and if positive, will be excluded.\n* Elevated liver enzymes (alkaline phosphatase, ALT, AST, bilirubin) as sign of hepatic disfunction if the laboratory results are available prior to study participation\n* Patients who appear intoxicated on any substance.\n* Patients who are wards of the state or prisoners as defined by DHS\n* Patients who are not deemed to be competent to provide consent or assent.","5 Years","20 Years",{"count":79,"type":21},120,[81],"PHASE2","The purpose of this research is to see if ketamine is effective and safe in treating children and young adults with sickle cell disease experiencing sickle cell related pain. In this study, we will compare the outcomes (such as pain scores) in persons who receive standard of care pain medicine (an opioid such as morphine) plus a low dose (amount) of ketamine to those who receive only standard of care pain medicine.",[28,84,85,86,27],"Vaso-Occlusive Pain Episode in Sickle Cell Disease","Ketamine Infusion","Pain Management",[28,88,89,90],"Vaso-Occlusive Pain Episode","Sub-Dissociative Ketamine","Pediatric Pain Management",{"date":59,"type":33},{"date":93,"type":21},"2026-04-01",{"date":95,"type":21},"2028-04-30",{"name":97,"class":40},"Mohsen Saidinejad",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":41},"100593034","impact-of-regional-anesthesia-on-inflammatory-mechanisms-during-vaso-occlusive-crisis-in-sickle-cell-patients-100593034","NCT07001189","Impact of Regional Anesthesia on Inflammatory Mechanisms During Vaso-occlusive Crisis in Sickle Cell Patients","ALRCVO-MP","Inclusion Criteria:\n\n* patients adult \\>18 years\n* patients with vaso-occlusive crisis\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Blood transfusion within the last 3 months\n* Lack of affiliation with the French social security system\n* Protected individuals",{"count":106,"type":21},34,"OBSERVATIONAL","Sickle cell disease is a chronic disease characterized by multiple vaso-occlusive complications. The basic treatment for patients with a vaso-occlusive crisis (VOC) is based on adequate hydration, oxygen therapy and pain control. Loco Regional Anesthesia (LRA) is one of the major treatments in resuscitation anesthesia for both anesthesia and analgesia. LRA allows effective and almost immediate pain control by blocking nerve afferents in a given area. LRA could decrease the inflammatory response during crises and accelerate resolution of the crisis.",[110,28,27],"Sickle Cell",[112,113,27],"Loco-regional anesthesia","inflammation","2025-05-23",{"date":116,"type":33},"2025-06-03",{"date":118,"type":33},"2025-02-05",{"date":120,"type":21},"2027-02-05",{"name":122,"class":40},"Centre Hospitalier Universitaire de la Guadeloupe"]