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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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>randomization</b>

    Assignment to a group to receive either the test medication or a placebo (a substance without active medicine).

  2. Step 2

    <b>infusion treatment</b>

    Administration of an infusion (medicine delivered through a tube into a vein) for a maximum of 5 days.

    The test medication is iloprost at a dose of 50 microgrammes per infusion.

    The placebo is glucose (a sugar solution) at a dose of 250 millilitres per infusion.

  3. Step 3

    <b>hospitalization</b>

    Stay in the hospital for a maximum of 21 days to manage the vaso-occlusive crisis (a painful event caused by blocked blood flow in sickle cell disease).

  4. Step 4

    <b>monitoring</b>

    Observation of opioid consumption (pain relief medication) for 28 days following the initial assignment to a group.

Who can join the trial?

10 criteria

  • 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 trial?

24 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

  • Iloprost

    This medication is an intravenous solution administered through a slow infusion into the bloodstream. It is used to treat conditions where blood flow is restricted, such as during painful crises in sickle cell disease. It works by mimicking a natural substance in the body that tells the muscles around blood vessels to relax, which helps the vessels widen and improves circulation. This substance belongs to a group of drugs known as prostacyclin analogues.

  • Glucose

    This is a sugar solution administered as an intravenous infusion to provide energy or maintain fluid balance. In this study, it is used as a placebo, meaning it has no active medicinal effect for the condition being tested. It acts simply by providing a source of fuel for the body's cells through the bloodstream. This substance is classified as a carbohydrate solution.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522005-38-00Protocol code2020/0421/HPEstimated enrolment144 patientsSponsorCentre Hospitalier Universitaire Rouen

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