RecruitingPHASE4INTERVENTIONAL

Prospective Study on the Role of Intravenous Unfractionated Heparin Following Digital Replantation and Revascularization

This study is investigating if giving a blood thinner called heparin through an IV can improve the success rates of reattaching fingers or toes after an injury. When a finger or toe is reattached, sometimes blood clots can form and stop the blood flow, causing the reattachment to fail. Researchers want to see if heparin helps prevent these clots, leading to a better outcome. They will compare patients who receive heparin with those who don't, checking to see if the reattached digit is healthy when they leave the hospital. The study also looks at potential side effects of heparin, like bleeding, and how things like smoking or other health conditions might affect success.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrolment target

188

Start

24 May 2021

Estimated completion

01 May 2027

Amputation; Traumatic, Hand

What is this study about?

Imagine you've had a serious injury where a finger or toe needed to be reattached. This delicate surgery, called replantation, involves reconnecting tiny blood vessels. For these reattached parts to survive and heal well, good blood flow is absolutely crucial. Sometimes, even after a successful surgery, tiny blood clots can form in the new connections, blocking the blood flow and causing the reattached part to fail. This is a big problem, and doctors are always looking for ways to improve the chances of success.

This study is looking at a medicine called heparin, which is a blood thinner. It's often used to prevent blood clots. The researchers want to find out if giving heparin through a drip into your vein after a finger or toe reattachment helps keep the blood flowing smoothly, preventing clots, and ultimately leading to a more successful reattachment. They will be comparing patients who receive this heparin treatment with those who don't, to see if it makes a real difference in how well the reattached digit survives.

Beyond just whether the reattachment holds, the study will also carefully watch for any potential downsides of using heparin. Like all medicines, blood thinners can have side effects, such as increasing the risk of bleeding. The researchers want to understand these risks better, so they can decide who might benefit most from heparin and how to use it safely. They'll also consider if things like whether you smoke, the type of injury you had, or other health problems affect how well the reattachment works.

Key takeaways

The study assesses if blood thinner (heparin) helps reattached fingers/toes.
It compares patients receiving heparin with those who don't.
Researchers will check for successful reattachment and potential side effects.
Participation lasts for your hospital stay after surgery.
Your general health and previous medications determine if you can join.

Who may be eligible?

To take part in this study, you must have had a finger or toe reattached or had surgery to restore blood flow to one (called revascularization) at the Centre hospitalier de l'Université de Montréal.

However, there are certain reasons why you might not be able to join. You can't participate if you were already taking certain blood-thinning medicines (like Warfarin, Eliquis, or Pradaxa) before your injury, though daily low-dose aspirin is usually okay. Also, if you have certain health conditions that make heparin unsafe for you, such as problems with blood clotting, severe liver damage, or a type of bleeding ulcer, you won't be able to join.

Finally, if the injury was higher up your arm (at the wrist or above) or if it was a very specific type of injury called a 'degloving' injury (where the skin and soft tissues are completely torn away), then this study isn't suitable for you. You need to be at least 14 years old to participate.

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.

Did I have a finger or toe reattached or revascularized at the Centre hospitalier de l'Université de Montréal?
Am I at least 14 years old?
Was I NOT taking blood-thinning medicines (other than daily aspirin) before my injury?
Do I NOT have existing health conditions that make heparin unsafe for me?
Was my injury to a finger or toe, and not higher up my arm or a 'degloving' type?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given heparin through an intravenous (IV) drip after your surgery. This means the medicine will go directly into your bloodstream through a small tube in your arm. The study team will regularly check how your blood is clotting to make sure you're getting the right amount of heparin. They will also closely monitor you for any potential side effects, such as bleeding or bruising.

During your hospital stay, doctors will check your reattached finger or toe to see how well it's healing and if it's healthy when you are ready to go home. There will be no extra hospital visits just for the study; all assessments will happen as part of your standard care until you are discharged. The total duration of your participation will be for the length of your hospital stay after your surgery.

Potential risks and benefits

Taking part in this study may offer potential benefits, as the heparin treatment could help improve the success of your finger or toe reattachment, leading to a better recovery. However, like all medical treatments, there are potential risks. Heparin, as a blood thinner, can increase the risk of bleeding, bruising, or in rare cases, other blood-related issues. The study team will carefully monitor you for these side effects. Your well-being is always the top priority, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

CHUM
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is heparin and why is it used?

Heparin is a medicine that helps prevent blood clots. In this study, it's being used to see if it can keep blood flowing well to reattached fingers or toes to help them heal.

Will I definitely get heparin if I join?

The study will compare patients who receive heparin with those who don't. You may or may not receive the heparin treatment. The study doctors will discuss this with you.

What happens if I experience side effects from heparin?

The study team will closely monitor you for any side effects, like bleeding. They will provide appropriate medical care if any issues arise.

How long will I be in the study?

Your participation will last only for the duration of your hospital stay after your surgery until you are discharged.

Will my regular doctor know I'm in the study?

Yes, all medical care is coordinated, and your medical team will be aware of your participation in the study.

How to find out more

Linda M Zhu

linda.zhu@mail.mcgill.ca 5148908000 Official trial record

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