Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Tranexamic acid during excisional burn surgery

This study is investigating a medicine called tranexamic acid, also known as Cyklokapron, to see if it can help reduce bleeding during surgery for burn injuries. Researchers will compare this medicine with a simple salty water solution, which is a common practice. The main aim is to find out if tranexamic acid lessens the amount of blood lost during the operation and how well the blood clots afterwards. They will also look at whether patients need fewer blood transfusions, how long they stay in hospital, and if their skin grafts are successful. Importantly, they'll check for any heart, lung, or brain complications during or after the surgery. This research will help doctors understand the best ways to care for burn patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Maasstad Ziekenhuis Stichting

Enrolment target

Start

26 Apr 2024

Burn injury

What is this study about?

This study is about helping people who need surgery for burn injuries. When someone has a severe burn, doctors sometimes need to operate to remove damaged tissue and prepare for skin grafts. During these operations, there can be a lot of bleeding, which can be a concern for patients and doctors.

Researchers are looking at a medicine called tranexamic acid. This medicine is already used safely in many other types of surgery to help reduce bleeding. In this study, they want to see if giving tranexamic acid during burn surgery can cut down on blood loss. They will compare it to a standard treatment, which is a saline solution (salty water).

The main things they will measure are how much blood is lost during the surgery and how well the blood clots to stop bleeding. They will also check if people need less blood transfusions, how long they need to stay in hospital, and if the skin grafts (where new skin is placed) are successful. The study will also carefully monitor for any serious side effects like problems with the heart, lungs, or brain.

Key takeaways

The study explores a medicine (tranexamic acid) to reduce bleeding in burn surgery.
It compares the medicine to a standard salty water solution.
Focus is on blood loss, need for transfusions, and recovery after surgery.
Participation is for adults aged 18 and over with burn injuries needing surgery.
Potential benefit is less bleeding; potential risks are carefully monitored.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

To take part in this study, you would need to be 18 years old or older. There is no upper age limit, meaning older adults are also welcome to join if they meet all other criteria. Both men and women can participate in this research.

To be considered for the study, you would typically be someone who is about to have surgery for a burn injury. The doctors running the study would carefully review your medical history and current health to make sure that taking part is safe and suitable for you. They would check for specific medical conditions or medications that might prevent you from joining.

Quick self-check

Are you 18 years old or older?
Are you about to have surgery for a burn injury?
Are you comfortable potentially receiving either the study medicine or a standard saline drip?
Do you understand that you will be monitored closely during and after surgery?
Are you willing to participate in follow-up checks during your recovery?

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 would receive either the study medicine (tranexamic acid) or a saltwater solution, given through a drip during your burn surgery. You wouldn't know which one you received, nor would your doctors, to ensure fair results. The study team would carefully monitor you during and after your surgery, paying close attention to blood loss, your need for blood transfusions, and how well you recover.

Throughout your hospital stay, the doctors and nurses would continue to check on your progress, including how long you stay in hospital and the success of any skin grafts. They would also monitor for any potential side effects or complications. There will be follow-up checks during your recovery period to gather information about your healing. The total duration of your participation would depend on your recovery, but the main measurements would occur during your surgery and hospital stay.

Potential risks and benefits

Participating in this study might offer a potential benefit of reduced blood loss during your burn surgery, which could lead to fewer blood transfusions and a smoother recovery. However, there's no guarantee you will experience these benefits. As with any medical treatment, there are potential risks associated with tranexamic acid, such as a very small chance of blood clots, though this is carefully monitored. The saltwater solution is generally considered very safe. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Netherlands

Common questions

What is tranexamic acid?

It's a medicine that helps reduce bleeding by strengthening blood clots.

What is a 'salty water solution'?

It's a common medical solution (like saline) often used in hospitals, and acts as a comparison in this study.

Will I know if I'm getting the medicine or the salty water?

No, neither you nor your doctors will know, which helps make the study results fair and unbiased.

What is the main thing the study wants to find out?

It wants to see if tranexamic acid reduces blood loss during burn surgery and helps with blood clotting.

Will this study affect my usual burn treatment?

No, this study is about adding to your care, not replacing standard treatments for burn injuries.