Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery
This research study is investigating if a medication called tranexamic acid can help reduce the need for blood transfusions in adults undergoing major surgery on their tummy. When people have big operations, they can sometimes lose a lot of blood, and a transfusion might be needed. Researchers want to see if giving tranexamic acid can prevent this. The study will compare tranexamic acid to a 'placebo', which looks like the medicine but contains no active drug. This helps scientists understand if any effects seen are truly due to the medicine. They will also be looking carefully at the safety of tranexamic acid in this situation.
At a glance
What is this study about?
When you have major surgery, especially on your tummy, there's always a risk of losing blood. Sometimes, if too much blood is lost, doctors need to give you a blood transfusion. A transfusion means you get donated blood to replace what you've lost, helping you recover better.
This study is looking at whether a particular medicine, called tranexamic acid, can help reduce the amount of blood you might lose during or after major abdominal (tummy) surgery. Tranexamic acid works by helping your blood to clot, which can stop heavy bleeding. The main goal is to find out if taking this medicine means fewer people will need a blood transfusion during or after their operation.
To figure this out, some patients will receive tranexamic acid, while others will receive a 'placebo'. A placebo looks exactly like the real medicine but doesn't contain any active drug. This is really important for scientific studies because it helps researchers confidently say whether any effects they see are truly due to tranexamic acid or just a coincidence. The study will also be carefully checking for any side effects of tranexamic acid to make sure it's safe to use in this situation.
Key takeaways
- The study investigates tranexamic acid's role in reducing blood transfusions.
- It's for adults having major surgery on their tummy.
- Participants will receive either tranexamic acid or a placebo.
- Safety is a key focus, alongside the medicine's effectiveness.
- The goal is to improve treatment for surgical patients.
Who may be eligible?
To be able to take part in this study, you need to be at least 18 years old. You must be planned to have a major operation on your tummy, such as surgery on your food pipe, stomach, bowel, pancreas, or liver. It's also important that your kidneys are working well.
For fairness and safety, there are certain reasons why you might not be able to join. For example, if you already have very low blood counts (severe anaemia), or if you have a known problem with your blood clotting (either too much or too little). If you've recently had a blood clot, or if you're allergic to tranexamic acid, you wouldn't be able to participate.
Women who could become pregnant would need a negative pregnancy test before starting the study and must agree to use very effective contraception throughout the study. This is to ensure the safety of both the mother and any potential baby.
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?
- Are you having a major tummy operation soon (e.g., on your stomach, bowel, liver)?
- Do you have healthy kidney function?
- Do you not have a serious bleeding disorder or a high risk of blood clots?
- Are you not severely anaemic (very low blood count)?
What does participation involve?
If you decide to take part in this study, you would first have a detailed discussion with the study team and sign a consent form. Before your tummy surgery, you would either receive tranexamic acid or a matching placebo (a dummy medicine). No matter which one you receive, you'd still get the standard care for your surgery. The study team would closely monitor you during and after your operation for any bleeding and to see if you need a blood transfusion. They would also keep an eye on your general health and any potential side effects. The total duration of your participation would depend on your recovery from surgery, but the key assessments related to the study medicine would focus on the period around your operation and immediate recovery.
Potential risks and benefits
Locations (2)
- University Hospital Carl Gustav Carus DresdenVerified postcodeDresden, Germany· Recruiting
- University Hospital, Dpt. of Abdominal, Vascular and Endocrine SurgeryVerified postcodeHalle, Germany· Recruiting
Common questions
What is tranexamic acid?
It's a medicine that helps your blood clot, which can reduce bleeding.
Why is this study important?
It helps us learn if tranexamic acid can safely reduce the need for blood transfusions during major surgery.
What is a placebo?
It's a dummy medicine that looks like the real drug but contains no active ingredients. It helps researchers compare effects.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your doctors will know during the study. This is called 'blinding' and helps keep the results fair.
Will my regular medical care be affected if I join?
No, you will still receive all the usual care for your surgery, whether or not you participate in the study.
How to find out more
Ulrich Ronellenfitsch, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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