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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
EU CTIS ID: 2025-522005-38-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.