2025-522005-38-00招募中3 期
Evaluation of the efficacy of iloprost in the management of vaso-occlusive crises in adult patients with sickle cell: a multicentre, randomised, double-blind, placebo-controlled study _ PROSTASICKLE
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 5
- 主要终点
- Mean opioid consumption in morphine equivalent mg/day over the 28 days following randomization
研究概览
简要总结
Evaluate the efficacy of a maximum 5-day infusion of iloprost compared to placebo on opioid consumption during hospitalization (with a maximum hospitalization duration of 21 days) for a vaso-occlusive crisis in adult patients with sickle cell disease.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with sickle cell disease (all genotypes)
- •Age ≥18 years.
- •Requiring hospitalisation and parenteral infusion of opioids for the treatment of a vaso-occlusive crisis
- •Admitted to the Adult Emergency Department or the Internal Medicine or Haematology Department for less than 36 hours.
- •Patient having read and understood the information letter and signed the consent form or oral consent obtained and consent retrieved within 48 hours of randomisation
- •For women: o Of childbearing age (defined by the CTCG as a fertile woman, after menarche and until menopause, except in cases of permanent infertility (including hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) o 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 Synopsis PROSTASICKLE – Protocol Summary Version 1.1 – 02/02/2026 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;. And, o Presenting a negative urinary pregnancy test at inclusion; o menopausal: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.
- •Affiliated to a social security scheme.
排除标准
- •Patients with a contraindication to iloprost (ILOPROST ZENTIVA 100 micrograms/mL, solution for dilution for infusion) o Pregnancy, breast-feeding. o Hypersensitivity to the active substance or to one of the excipients. o Conditions where the risk of bleeding may be increased due to the effects of iloprost on platelets. o Severe coronary heart disease or unstable angina. o Myocardial infarction within the previous six months. o Acute or chronic heart failure (NYHA classification II to IV). o Severe arrhythmias. o Suspected pulmonary congestion
- •Severe malnutrition
- •Thiamine deficiency in chronic alcoholic patients
- •Patient presenting with arterial hypotension
- •History of documented opioid dependence
- •Active smoking
- •Patients with liver failure or kidney failure requiring dialysis
- •Patients who have had a cerebrovascular event in the last 3 months
- •Person deprived of liberty by an administrative or judicial decision or person placed under court protection / sub-guardianship or guardianship.
- •Patient already included in the PROSTASICKLE protocol within 90 days of randomisation
- •Patient participating in another therapeutic trial or having participated in another trial within 1 months of inclusion
- •Patient presenting with a contraindication to 5% glucose (Glucose 5% FRESENIUS KABI France solution for infusion): a. Hypersensitivity to corn b. Uncontrolled hyperglycemia, c. Decompensated diabetes, d. Other known glucose intolerances (e.g. situations of metabolic stress, acute shock states, collapse), e. Hyperosmolar coma, f. Hyperlactatemia, g. Metabolic acidosis, h. Fluid overload. The administration of high volumes may in particular result, due to fluid overload, in the following contraindications: i. Hyperhydration j. Acute heart failure k. Pulmonary edema
- •Hypersensitivity to 5% glucose
研究组 & 干预措施
ILOPROST ZENTIVA 100 microgrammes/mL, solution à diluer pour perfusion
Test
干预措施: ILOPROST ZENTIVA 100 microgrammes/mL, solution à diluer pour perfusion (Drug)
Glucose 5 % Fresenius Kabi, solution pour perfusion
Placebo
干预措施: Glucose 5 % Fresenius Kabi, solution pour perfusion (Drug)
结局指标
主要结局
Mean opioid consumption in morphine equivalent mg/day over the 28 days following randomization
Mean opioid consumption in morphine equivalent mg/day over the 28 days following randomization
次要结局
未报告次要终点
研究者
Delphine PICOCHE
Scientific
Centre Hospitalier Universitaire Rouen
研究点 (5)
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