RecruitingPHASE3INTERVENTIONAL

Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial

This study, called BRACKETS, is looking at two common medicines, tranexamic acid and desmopressin, in people with kidney disease who are having surgery. The main goal is to see if these medicines can help reduce serious bleeding during and after the operation. Doctors already know these medicines can help reduce bleeding in many surgeries, but they haven't been widely tested in people with severe kidney problems. Because this is a "pilot" study, it means it's a smaller, early-stage trial. Its main purpose is to help design a much larger future study and gather some initial information about how safe and effective these medicines might be specifically for patients with kidney disease having non-heart-related surgery. This way, doctors can learn how best to protect these patients during surgery.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Hamilton Health Sciences Corporation

Enrolment target

100

Start

09 Jun 2025

Estimated completion

01 Jun 2027

Chronic Kidney Diseases Acute Kidney Injury Bleeding Surgery

What is this study about?

This study, called BRACKETS, is looking into important questions for people with kidney disease who need surgery. When someone has surgery, there's always a risk of bleeding. For people with kidney disease, this risk can sometimes be higher, and it's extra important to manage it safely. Doctors often use medicines to help reduce bleeding during operations, but many of the big studies about these medicines haven't included people with advanced kidney disease. This means there's less information about how well these medicines work and if they are fully safe for this specific group of patients.

The BRACKETS study is focusing on two medicines: tranexamic acid and desmopressin. These medicines have been around for a long time and are commonly used. Tranexamic acid helps your blood clot, and desmopressin can help with a specific part of blood clotting that can be affected by kidney disease. This study is specially designed to see if giving these medicines before surgery can help reduce bleeding in people with moderate to severe kidney disease or those on dialysis, who are having surgery that isn't on their heart.

Because this is a "pilot" study, it's like a practice run for a much larger study in the future. The main goals are to make sure a bigger study would be practical, to help design it better, and to gather some early information on whether these medicines are effective and safe for people with kidney disease. The information from this smaller study will be crucial for doctors around the world to understand the best ways to care for patients with kidney disease undergoing surgery, ultimately aiming to make surgery safer for everyone.

Key takeaways

A study looking at ways to reduce bleeding during surgery for people with kidney disease.
Investigating two common medicines: tranexamic acid and desmopressin.
It's a pilot study to help design a larger, future trial.
You might receive active medicine or a placebo before your non-heart surgery.
Participation helps doctors improve surgical care for kidney patients worldwide.

Who may be eligible?

To join this study, you would need to be an adult (18 years or older) and be planning to have surgery that is not on your heart. You would also need to have kidney disease, which means your kidneys aren't working as well as they should, or you are currently receiving dialysis treatment.

There are certain reasons why you might not be able to join. For example, if you are having heart surgery or brain surgery, or if you have a history of certain serious blood clots, strokes, or seizures. Also, if you know you're allergic to one of the study medications, or if you're pregnant or breastfeeding, you wouldn't be able to participate. For women who could become pregnant, a negative pregnancy test and effective contraception might be needed.

The doctors will look at your health records, including your kidney function and other medical conditions, to see if this study is right for you. They will explain everything clearly to make sure you understand.

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?
Do you have kidney disease or are you on dialysis?
Are you having surgery that is NOT on your heart?
Do you not have a history of recent serious blood clots, strokes, or seizures?
Are you not pregnant or breastfeeding, and for women who could get pregnant, are you using effective birth control?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either one of the study medicines (tranexamic acid or desmopressin) or a placebo (a dummy medicine that looks like the real thing but has no active ingredients) shortly before your surgery, through an injection. You might receive one study medicine, both, or a combination with placebo, depending on which group you are in. You wouldn't know which one you are getting, and neither would your study doctor.

Your usual surgery and recovery would go ahead as planned. The study team would carefully monitor you during and after your operation for any bleeding and to see how you are recovering. They would collect information from your hospital stay, including any blood tests. There might be follow-up health checks after you leave the hospital, but these would mostly involve reviewing your medical notes rather than extra appointments. The total duration of your participation would cover your surgery and recovery period.

Potential risks and benefits

Participating in this study might offer a potential benefit if one of the medicines helps reduce bleeding during your surgery. However, because it's a pilot study, the main benefit is for future patients, as the information gained will help doctors figure out the best ways to protect people with kidney disease during surgery. As with any medication, there are potential risks and side effects associated with tranexamic acid and desmopressin, which doctors will explain in detail. These can include allergic reactions or, rarely, an increased risk of blood clots for tranexamic acid, and changes in fluid or salt balance for desmopressin. You have the right to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (3)

London Health Sciences Centre
Verified postcode
London, Canada· Recruiting
Centre Hospitalier de L'Universite de Montreal (CHUM)
Verified postcode
Montreal, Canada· Active not recruiting
McGill University University Health Centre
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is a pilot study?

A pilot study is a smaller, early-stage study designed to check if a larger study is possible to do and to help plan it better. It also gives us early information.

What is a placebo?

A placebo is a 'dummy' treatment that looks exactly like the real medicine but contains no active ingredients. It helps doctors understand if the medicine itself is working.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This helps make the study results fair and accurate.

What kind of surgery is included in this study?

This study is for people having non-heart related surgery, which means any operation that is not on your heart.

Will taking part affect my usual medical care?

No, your regular medical care and decisions about your surgery will continue as normal. This study is an addition to your standard care.

How to find out more

Ingrid Copland

brackets@phri.ca 905-296-5754 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.