Phase IIb Multicenter Randomized Controlled Trial Evaluating the Efficacy of Sivelestat in Patients with Septic Coagulopathy
This research study is looking into a new medicine called Sivelestat for people who have a serious condition known as septic coagulopathy. This condition happens when a severe infection (sepsis) affects how your blood clots, which can be very dangerous. The main goal is to find out if Sivelestat can help reset the blood's natural clotting balance within 24 hours. Researchers will also be checking other important health markers to understand how the treatment affects the body, how patients feel, and if it helps with recovery. The study also carefully monitors for any side effects to make sure the treatment is safe.
At a glance
What is this study about?
This study is about a serious illness called septic coagulopathy. This happens when a severe infection, known as sepsis, causes problems with how your blood clots. Your blood might clot too much or not enough, both of which can be very dangerous and lead to serious health problems, including organ damage. The researchers want to see if a new treatment, called Sivelestat, can help people with this condition.
The main aim of this study is to check if Sivelestat can help get your blood's clotting system back to normal within the first 24 hours of treatment. The researchers will be comparing Sivelestat to a 'placebo', which looks like the real treatment but doesn't contain any active medicine. This helps them understand whether any changes they see are truly due to the Sivelestat.
Beyond just looking at blood clotting, the study will also explore whether Sivelestat can improve other important aspects of your health. This includes how your organs are working, how long you might need support like breathing machines, and your overall recovery. They will also be very carefully watching for any side effects to ensure the treatment is as safe as possible for patients.
Key takeaways
- This study investigates a new treatment for severe infection-related blood clotting issues.
- It aims to make blood clotting normal again and improve patient recovery.
- Patients will receive either the new drug or a dummy treatment through an IV drip.
- Regular blood tests and health checks will happen for several weeks.
- All side effects will be carefully monitored.
- You can stop participating at any time without affecting your care.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. There's no upper age limit, meaning older adults can also take part. The study is open to both men and women.
The most important thing is that you have been diagnosed with septic coagulopathy, which is a specific problem with blood clotting caused by a severe infection. The medical team will check your health very carefully to see if you meet all the necessary requirements.
They will have specific criteria based on your current health status and medical history to make sure the study is right and safe for you. It's important to discuss your full medical background with the study team.
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 at least 18 years old?
- Do you have a diagnosis of septic coagulopathy (severe infection affecting blood clotting)?
- Are you able to agree to the study requirements?
- Have you discussed your full medical history with your doctor?
What does participation involve?
If you decide to take part in this study, you will either receive the new treatment, Sivelestat, or a placebo, which looks identical but has no active medicine. You won't know which one you're getting, nor will your doctors, to keep the study fair. Both Sivelestat and the placebo will be given to you through a drip.
The main part of the study will involve regular blood tests over seven days to check how your blood is clotting and how other health markers are changing. These tests will be done on day 1 (when you start), day 2, day 3, day 4, and day 7. Researchers will also keep an eye on your overall health and how your body is responding to treatment for up to 28 days, and some aspects will be checked up to 90 days.
Throughout the study, the medical team will be closely monitoring your health, looking for any changes in your condition, and carefully recording any side effects you might experience. The total duration of your active participation, including medical check-ups, will vary but involves assessments up to 90 days after starting treatment.
Potential risks and benefits
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Common questions
What is septic coagulopathy?
It's a serious problem where a severe infection (sepsis) affects how your blood clots, either making it clot too much or not enough.
What is Sivelestat?
Sivelestat is the new medicine being tested in this study to see if it can help fix the blood clotting problems caused by septic coagulopathy.
Will I definitely get the new treatment?
No, you might receive Sivelestat or a placebo (a dummy treatment). Neither you nor your doctor will know which one you're getting during the study.
How long will the study last?
The main treatment and close monitoring last about 7 days, but your health will be checked up to 90 days after starting the treatment.
What are the main risks?
The main risks are potential side effects, especially those related to bleeding or clotting, which will be carefully watched for by the medical team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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