Influence of Argipressin on blood loss during liver resection; a double-blinded, randomized, placebo-controlled trial (ARG-01)
This study is investigating a new approach to reduce blood loss during liver surgery. When people need liver surgery, either for cancer or other conditions, there can sometimes be significant bleeding. This trial is testing a medicine called argipressin to see if it can help lessen the amount of blood lost during the operation. Patients will be randomly given either argipressin or a dummy treatment (placebo). Doctors will carefully measure blood loss and monitor other health markers to understand how safe and effective argipressin is. The aim is to find ways to make liver surgery safer for patients by reducing complications related to bleeding.
At a glance
What is this study about?
When people need an operation on their liver, whether it's for cancer, a tumour that has spread from another part of the body, or a non-cancerous growth, one of the challenges can be managing blood loss during the surgery. Losing too much blood can lead to further complications and a longer recovery time.
This study, called ARG-01, is looking into whether a specific medicine, called argipressin, can help reduce how much blood a patient loses during their liver operation. It's a 'Phase II' trial, which means doctors are exploring if the treatment works and is safe. They want to understand its effects more thoroughly before it can be used more widely.
To get clear results, some patients will receive the argipressin medicine, while others will receive a 'placebo', which is a harmless dummy treatment that looks just like the real medicine but contains no active drug. This is done to fairly compare the effects of argipressin. Doctors will carefully measure the blood lost during surgery and keep a close eye on various health signs and how patients recover afterwards. The ultimate goal is to find better ways to help patients undergoing liver surgery.
Key takeaways
- This study aims to reduce bleeding during liver surgery.
- It tests a medicine called argipressin against a dummy treatment.
- Both men and women aged 18+ needing liver surgery can apply.
- Participation involves monitoring before, during, and after surgery.
- The goal is to find safer ways to perform liver operations.
Who may be eligible?
To be considered for this study, you must be at least 18 years old and need surgery on your liver. This surgery could be because you have a primary liver cancer, cancer that has spread to your liver from another part of your body (metastasis), or a non-cancerous growth (benign tumour) that requires removal.
Both men and women can take part in this study. The medical team will check your overall health and specific details about your liver condition to make sure this study is right for you and safe for you to participate.
- Are you 18 years old or older?
- Do you need surgery on your liver?
- Is your liver surgery for a diagnosed tumour (cancerous or non-cancerous)?
- Are you willing to potentially receive either the study drug or a placebo?
- Can you attend follow-up visits after your surgery?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will be invited to discuss the trial in detail with the study team. If you agree, you will be randomly assigned to receive either the study medicine (argipressin) or a dummy treatment (placebo) during your liver surgery. Neither you nor your doctors will know which treatment you are receiving – this is called 'double-blinded' and helps ensure the results are fair.
During and after your surgery, the medical team will carefully monitor your health. They will measure the amount of blood lost during the operation and check various blood tests and other health markers at specific times, including on the day of surgery and for several days afterwards. This will involve blood samples and checks on your blood pressure, heart rate, and urine output. Your recovery, including any complications and how long you stay in hospital, will also be monitored for about a month after your surgery. The total duration of active follow-up will be for a few days immediately after surgery, with a final check around 30 days later.
Potential risks and benefits
Locations (1)
- —Sweden
Common questions
What is liver resection?
Liver resection is a type of surgery where a part of your liver is removed, usually because of a tumour or other disease.
What is a placebo?
A placebo is a substance that looks exactly like the study medicine but doesn't contain any active drug. It's used to compare against the real medicine.
Why is blood loss important during surgery?
Reducing blood loss during surgery can help prevent complications, reduce the need for blood transfusions, and improve recovery.
Will I know if I'm getting the active medicine or the placebo?
No, both you and your doctors will not know which treatment you are receiving until the study is over. This helps ensure the results are unbiased.
How long will I be monitored after surgery?
You will be closely monitored for several days after your surgery, with a final check-up around 30 days later to see how you're recovering.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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