RecruitingPHASE3INTERVENTIONAL

Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass

This study focuses on patients needing heart surgery that involves a heart-lung machine. Sometimes, the usual blood-thinning medicine, heparin, doesn't work well for everyone. This is called being 'heparin-resistant'. The study is testing a new medicine called Atenativ, which is made from human plasma (the liquid part of blood). Researchers want to see if Atenativ can help these patients respond better to heparin, making their blood thin enough for surgery, and if it's safe to use. This is a Phase 3 trial, which means it's a later stage of testing, often comparing the new treatment to a dummy treatment (placebo) to see how well it works.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Octapharma

Enrolment target

120

Start

21 Aug 2024

Estimated completion

01 Mar 2028

Acquired Antithrombin Deficiency

What is this study about?

Imagine you're having heart surgery, and doctors need to use a special machine to temporarily take over for your heart and lungs. To prevent blood clots during this time, doctors give you a blood-thinning medicine called heparin. However, for some people, heparin doesn't work as well as it should. This study is for those patients, specifically looking at a medicine called Atenativ.

Atenativ is a treatment derived from human plasma, which is the clear, yellowish liquid part of your blood. It contains something called antithrombin, which is a natural substance in your body that helps control blood clotting. The goal of this study is to see if giving Atenativ to patients who don't respond well to heparin can help their blood thin properly before and during heart surgery.

This is a 'Phase 3' study, meaning it's a large trial that compares Atenativ to a placebo (a dummy treatment with no active medicine) to understand how effective and safe it is. By finding better ways to manage blood thinning during complex heart surgeries, we can help make these procedures safer and more successful for patients.

Key takeaways

This study is for adults having heart surgery who don't respond well to standard blood thinners.
It tests a new medicine called Atenativ, made from human blood plasma.
The aim is to see if Atenativ safely helps blood thin properly during surgery.
Some people will receive Atenativ, others a dummy treatment (placebo).
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to be an adult between 18 and 85 years old. You must be planning to have heart surgery that requires using a heart-lung machine, and your doctors must have found that you don't respond well to the usual blood-thinning medicine called heparin.

There are also some reasons you wouldn't be able to join. For example, if you're taking certain blood thinner medicines right now or have recently taken them, or if you have a history of certain bleeding problems or kidney issues. Also, you can't be allergic to the ingredients in Atenativ or have a history of bad reactions to blood products.

Quick self-check

Are you between 18 and 85 years old?
Are you having heart surgery involving a heart-lung bypass machine?
Have your doctors said you don't respond well to heparin (a blood thinner)?
Are you free of certain other serious health issues or recent medications?
Are you willing to potentially receive blood-derived products?

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 first have a screening visit to check if you meet all the requirements. Before your heart surgery, you would receive either the study medicine (Atenativ) or a dummy treatment (placebo). This would likely be given as an infusion (drip) before your surgery begins and potentially during or after the procedure, depending on what the doctors decide is best for your care within the study guidelines. You would be closely monitored throughout your hospital stay. The study involves several checks and tests to see how your body responds to the treatment and to ensure your safety. All participants will be asked to give their permission (informed consent) to take part.

Potential risks and benefits

Taking part in this study could offer potential benefits, such as receiving a treatment that might help your blood thin more effectively during heart surgery if you don't respond to standard heparin. However, like all medicines, Atenativ might have side effects, and some people may experience an allergic reaction. There's also uncertainty about whether the treatment will work for everyone, as some participants will receive a placebo. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (27)

Stanford University School of Medicine
Stanford, United States· Recruiting
University of Miami
Miami, United States· Recruiting
Massachusetts General Hospital
Boston, United States· Recruiting
Duke University Medical Center
Durham, United States· Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, United States· Recruiting
Cleveland Clinic
Cleveland, United States· Not yet recruiting
The Ohio State University
Columbus, United States· Recruiting
OU Health University of Oklahoma Medical Center
Oklahoma City, United States· Recruiting
University of Texas Southwestern Medical Center
Dallas, United States· Recruiting
University Hospital Innsbruck
Innsbruck, Austria· Recruiting
Vienna General Hospital AKH, Medical University of Vienna
Vienna, Austria· Recruiting
Royal Columbian Hospital
New Westminster, Canada· Recruiting

+15 more sites — see the official record for the full list.

Common questions

What is 'heparin resistance'?

It means your body doesn't respond well to the usual blood-thinning medicine called heparin, which is important during heart surgery to prevent clots.

What is Atenativ?

Atenativ is a medicine made from human plasma that contains antithrombin, a natural substance in your blood that helps control clotting.

What is a 'placebo'?

A placebo is a dummy treatment that looks like the real medicine but contains no active ingredients. It helps doctors compare the effects of the active medicine.

Will I know if I'm getting Atenativ or the placebo?

No, this is a 'blinded' study, meaning neither you nor your doctors will know whether you're receiving Atenativ or the placebo until after the study is complete, unless there's a medical emergency.

Does this mean my usual care will change?

The study treatment is given in addition to your standard care. Your doctors will continue to provide the best medical care for your heart condition.

How to find out more

Cristina Solomon, MD

Cristina.Solomon@octapharma.com +41 79 585 90 42 Official trial record

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