AuthorisedTherapeutic confirmatory (Phase III)Interventional

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

This research study, called PROSTASICKLE, is investigating a medicine called iloprost for adults experiencing painful sickle cell crises. Sickle cell anaemia can cause severe pain when blood cells block small blood vessels. The study wants to find out if iloprost can reduce the amount of strong pain relief (like morphine) people need during these painful episodes. It's a large-scale study, meaning it involves many people, and is designed to compare iloprost against an inactive substance (placebo) to truly understand its effects. All participants will be over 18, and both men and women can take part. The goal is to see if iloprost could offer a new and effective way to manage these difficult crises.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire Rouen

Enrolment target

144

Start

09 Mar 2026

sickle cell anaemia with vaso-occlusive crisis

What is this study about?

Sickle cell anaemia is a condition that affects your red blood cells. Normally, red blood cells are round and flexible, carrying oxygen around your body. However, with sickle cell anaemia, some red blood cells become C-shaped, like a sickle. These 'sickle' cells are stiff and can get stuck in small blood vessels, blocking blood flow and causing sudden, very painful episodes called vaso-occlusive crises. These crises are a common reason for people with sickle cell to go to hospital and often require strong pain medication.

This study is looking into a medicine called iloprost. Iloprost is thought to help open up blood vessels, which might improve blood flow and reduce the pain during a sickle cell crisis. The main aim of this research is to see if iloprost can lessen the amount of strong painkillers people need over the 28 days following a crisis. If it works, it could mean a better quality of life and less severe pain management for those living with sickle cell anaemia.

This is a 'Phase III' study, which means it’s one of the final steps before a new treatment might become widely available. It's designed to confirm whether iloprost is truly effective and safe when compared to a 'dummy' treatment (placebo). Your participation would be very valuable in helping doctors understand if iloprost could be an important new option for managing sickle cell crises.

Key takeaways

This study evaluates iloprost for painful sickle cell crises.
It aims to reduce the need for strong pain medication.
It's a large, important study comparing iloprost to a placebo.
Only adults aged 18 and over can participate.
Participation involves infusions and careful monitoring.
You have the right to leave the study at any time.

Who may be eligible?

This study is looking for adult patients who have sickle cell anaemia and are currently experiencing a painful crisis, which is also known as a vaso-occlusive crisis. The study needs people who are 18 years old or older. There is no upper age limit, so older adults can also take part.

Both men and women are welcome to join this study. The researchers want to include a wide range of people to make sure the results apply to many different individuals living with sickle cell.

There might be other specific health requirements or conditions that mean you can or cannot join, but these would be discussed in detail by the study doctor to make sure the study is safe and right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have sickle cell anaemia?
Are you currently experiencing a painful sickle cell crisis?
Are you able to visit the hospital for treatment and follow-up?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would first have a full health check-up to make sure the study is suitable for you. If you qualify, you would be randomly assigned to receive either the study drug, iloprost, or a placebo (an inactive substance that looks just like the study drug). This is done by chance, like flipping a coin, and neither you nor your doctor will know which one you are receiving.

The study drug or placebo will be given to you as a drip into your arm (an infusion). You would receive this treatment in the hospital. The study team would carefully monitor you throughout your stay. Over the 28 days following the start of your treatment, the main thing the study will track is how much strong pain medication you need.

You would have regular check-ups and assessments by the study team, which might include blood tests, discussions about your pain levels, and how much pain relief you are using. The total duration of your participation in the study, including all follow-up, would be fully explained by the study team. You can stop participating at any time.

Potential risks and benefits

Taking part in this study could potentially offer benefits, such as receiving a new treatment that might improve your pain during a sickle cell crisis. You will also receive careful medical monitoring throughout your participation. However, like all medications, iloprost can have side effects, and some people might experience discomfort from the infusions or blood tests. You will be told about all known potential risks before you decide to join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is sickle cell anaemia?

It's a condition where some of your red blood cells are C-shaped and stiff, which can block blood vessels and cause severe pain.

What is a vaso-occlusive crisis?

It's a very painful episode that happens when sickle cells block small blood vessels, interrupting blood flow.

What is iloprost?

It's a medicine being tested in this study that is thought to help open up blood vessels during a crisis.

Why is this a 'double-blind' study?

Neither you nor your doctor will know if you're getting the active drug or a dummy treatment, which helps make the results fairer and more accurate.

How long will I be in the study overall?

The main part of the study tracks your pain relief needs for 28 days, but the full duration, including check-ups, will be explained by the study team.