AuthorisedTherapeutic confirmatory (Phase III)Interventional

ASPIRIN - Acetylsalicylic acid versus placebo in addition to a local non-steroidal anti-inflammatory drug in the treatment of thrombotic episodes in superficial venous malformations in children aged 6 to 17 years: a controlled randomised, double-blind, cross-over, multicenter trial

This medical study is for children aged 6 to 17 who experience painful blood clots in their superficial venous malformations. Researchers want to find out if taking a small dose of aspirin, in addition to using a pain-relieving gel (diclofenac), is more effective at reducing pain than using the gel with a dummy pill (placebo). The study will last 3 to 14 days and will carefully track pain levels, how much other pain medication is needed, and impact on the child's quality of life and sleep. It's a 'double-blind' study, meaning neither the patient nor the doctor will know who is getting the aspirin.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Regional Universitaire De Tours

Enrolment target

Start

25 Feb 2026

Thrombotic episodes in superficial venous malformations in children

What is this study about?

This study is looking into a painful condition where children get blood clots in their shallow veins, which are called superficial venous malformations. These clots can be very uncomfortable. We already know that a pain-relieving gel, like diclofenac, can help. This study wants to see if adding a small dose of aspirin, taken by mouth, makes an even bigger difference to the pain.

The study will compare two groups of children. One group will receive the pain gel along with a small dose of aspirin. The other group will receive the pain gel along with a dummy pill, called a placebo, which looks just like aspirin but contains no medicine. This helps researchers figure out if any changes are truly due to the aspirin or just the general care.

The main goal is to see which combination is better at reducing pain over a period of 3 to 14 days. We will also be looking at how this treatment affects the child's overall quality of life, their sleep, and if it reduces the need for other pain medications. We'll also be checking for any side effects to make sure the treatments are safe.

Key takeaways

Aims to reduce pain from clots in children's veins.
Compares aspirin plus gel to a dummy pill plus gel.
Children aged 6-17 with current painful clots are eligible.
Study lasts 3-14 days for treatment.
Monitors pain, quality of life, sleep, and safety.
You can withdraw your child anytime.

Who may be eligible?

This study is specifically looking for children between the ages of 6 and 17 years old. They must be experiencing new, painful blood clots in their superficial venous malformations.

All children, regardless of their gender, are welcome to participate if they meet the other study requirements. The doctors will also check other health details to make sure it's safe for a child to join the study.

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.

Is my child between 6 and 17 years old?
Does my child currently have a painful blood clot in a superficial venous malformation?
Is my child generally healthy enough to participate in a study?
Are we able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If your child takes part, they will receive either a small dose of aspirin or a dummy pill, alongside a pain-relieving gel, for 3 to 14 days. Neither you nor your child, nor the study doctors, will know which treatment they are receiving. You will need to bring your child to the clinic at the start of the study and then again for check-ups.

During these visits, and sometimes daily at home, the study team will ask about your child's pain levels using simple scales. They will also ask about how the condition affects their daily life and sleep. There will be blood tests to check how the treatment affects blood clotting and to monitor for safety. The total duration of active treatment will be 3 to 14 days, followed by further monitoring as needed.

Potential risks and benefits

Participating in this study might offer your child the potential benefit of better pain relief for their blood clots. However, it's also possible they might receive the dummy pill, which may not offer additional pain relief beyond the gel. As with any medication, there can be risks or side effects from aspirin, and the study team will monitor your child carefully for these. You have the right to withdraw your child from the study at any time, for any reason, without it affecting their ongoing 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 a 'superficial venous malformation'?

It's a type of birthmark made of veins that are close to the surface of the skin. Sometimes, blood clots can form in these veins, causing pain.

What does 'aspirin versus placebo' mean?

It means one group gets actual aspirin, and another group gets a dummy pill (placebo) that looks the same but has no medicine. This helps doctors see if the aspirin really works.

Will my child know if they are getting aspirin or the dummy pill?

No, this is a 'double-blind' study, meaning neither your child, you, nor the doctors involved will know who is getting which treatment until after the study is over.

How long will my child need to be in the study?

Your child will receive the study treatment for 3 to 14 days, with follow-up appointments and monitoring during and after this period.

What kind of pain medication will be used in the study?

All children will use a pain-relieving gel called diclofenac. The study investigates if adding aspirin makes it more effective.