Study of the effectiveness of iloprost compared to a placebo for treating vaso-occlusive crises in adults with sickle cell disease

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What is this study about?

This study focuses on individuals with Sickle Cell Disease, a condition where red blood cells become misshapen and can block blood flow. The investigation specifically looks at vaso-occlusive crisis, which is a painful episode caused by these misshapen cells blocking small blood vessels. The purpose of the study is to evaluate the effectiveness of iloprost in managing these painful episodes. Participants will receive either iloprost or a placebo through an infusion, which is a method of delivering fluids directly into a vein.

During the study, the treatment will be administered over a period of up to five days. The researchers will observe the impact of the medication on the amount of opioid, a type of strong pain medicine, required by patients during their time in the hospital. The total hospital stay for these episodes may last up to 21 days.

Who Can Join the Study?

You must have sickle cell disease, which is a genetic blood disorder that affects how red blood cells function.
You must be 18 years of age or older.
You must be experiencing a vaso-occlusive crisis, which is a painful episode caused by sickle-shaped blood cells blocking blood flow in your vessels.
You must require hospitalization and parenteral infusion of opioids, meaning you need to stay in the hospital and receive strong pain medication through a vein.
You must be admitted to the Emergency Department, Internal Medicine, or Haematology (blood specialty) department for less than 36 hours.
You must have read and understood the study information and provided consent, which is your formal agreement to participate.
For women of childbearing age (those who can become pregnant), you must use a highly effective form of contraception (methods to prevent pregnancy) for at least 4 weeks before starting and throughout the study.
For women of childbearing age, you must have a negative urinary pregnancy test at the start of the study.
For women who are menopausal (no longer having menstrual periods for at least 12 months), you must meet specific medical criteria to confirm this status.
You must be covered by a social security scheme (health insurance or government healthcare coverage).

Who Cannot Join the Study?

Being pregnant or breast-feeding.
Having an allergy or hypersensitivity (an extreme immune reaction) to the study medication or any of its ingredients.
Having medical conditions that increase the risk of bleeding because the medicine can affect platelets (the cells in your blood that help it clot).
Having severe coronary heart disease (serious blockage or problems with the arteries supplying the heart) or unstable angina (chest pain that is unpredictable or worsening).
Having had a myocardial infarction (a heart attack) within the last six months.
Having acute or chronic heart failure (a condition where the heart cannot pump blood well enough to meet the body’s needs), specifically classified as moderate to severe.
Having severe arrhythmias (irregular heartbeats).
Having suspected pulmonary congestion (a buildup of fluid in the lungs).
Being suffering from severe malnutrition (not having enough nutrients for the body to function properly).
Having a thiamine deficiency (a lack of Vitamin B1), especially in people who drink alcohol regularly.
Having arterial hypotension (abnormally low blood pressure).
Having a documented history of opioid dependence (a physical or mental addiction to strong pain relief medicines).
Being an active smoker.
Having liver failure or kidney failure that requires dialysis (a medical process that cleans the blood when the kidneys cannot).
Having had a cerebrovascular event (such as a stroke) within the last 3 months.
Being under court protection, guardianship, or held in custody by legal or administrative decisions.
Having participated in the PROSTASICKLE protocol (a specific medical study) within the last 90 days.
Participating in another medical trial or having been in one within the last month.
Having a reason why 5% glucose (a sugar solution used for fluids) cannot be used, such as an allergy to corn.
Having uncontrolled hyperglycemia (blood sugar levels that are too high) or decompensated diabetes (diabetes that is not being properly managed).
Having other glucose intolerances, such as issues caused by extreme physical stress or shock.
Having experienced a hyperosmolar coma (a life-threatening state caused by very high blood sugar), hyperlactatemia (high levels of lactic acid in the blood), or metabolic acidosis (too much acid in the body fluids).
Having fluid overload (too much fluid in the body), which can lead to hyperhydration (excessive water in the body), acute heart failure, or pulmonary edema (fluid buildup in the lungs).
Having an allergy to 5% glucose.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Groupe Hospitalier du Havre – Hôpital Jacques Monod	Montivilliers	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Ccyegg Hujhcaamgwu Itagqgjgniwaxe Ezlknvn Lmombzygk Vms dm Retac	Saint Aubin Les Elbeuf	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.09.2026

Trial locations

Investigated drugs:

ILOPROST

Iloprost is a medication given through an IV drip to help widen blood vessels. In this study, it is being tested to see if it can help manage the intense pain caused by sickle cell disease when blood flow becomes blocked.

Investigated diseases:

Sickle cell anaemia with vaso-occlusive crisis – This condition is a hereditary blood disorder where red blood cells develop an abnormal, crescent shape. These sickle-shaped cells are less flexible and can become stuck in small blood vessels. This blockage restricts blood flow and prevents oxygen from reaching various parts of the body. This process leads to episodes of intense pain known as a vaso-occlusive crisis. During these episodes, the lack of blood flow can cause damage to tissues and organs. The frequency and severity of these crises can vary among individuals.

Trial ID:

2025-522005-38-00

Protocol code:

2020/0421/HP

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of the effectiveness of iloprost compared to a placebo for treating vaso-occlusive crises in adults with sickle cell disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?