Active not recruitingPHASE3INTERVENTIONAL

Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial

This study, called FASTEST, is looking into a potential new treatment for a serious type of stroke where there's bleeding inside the brain (intracerebral haemorrhage). Researchers want to find out if a drug called rFVIIa (Recombinant Factor VIIa) can help stop or reduce this bleeding if given very soon after the stroke happens. The aim is to see if this could lead to better recovery for patients after six months, compared to standard care. The study is taking place in several countries, including the UK, and uses special procedures to give the treatment quickly, sometimes even in mobile stroke units.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Joseph Broderick, MD

Enrolment target

860

Start

03 Dec 2021

Estimated completion

01 Jan 2028

Intracerebral Hemorrhage

What is this study about?

Imagine your brain is like a very complex computer, and sometimes a blood vessel inside it can burst, causing bleeding. This is called an intracerebral haemorrhage, a serious type of stroke. Doctors are working hard to find better ways to treat this condition and help people recover.

This study, called FASTEST, is investigating a drug called rFVIIa. It’s thought that this drug might help to clot the blood and reduce the bleeding in the brain if given very quickly after the stroke. The main goal is to see if taking this drug within two hours of the stroke can improve a patient's recovery after six months and reduce how much the bleeding grows. This is a "Phase III" study, which means it’s one of the final steps before a treatment might be made widely available, if it proves safe and effective.

To make sure the study gives reliable results, some patients will receive the drug rFVIIa, while others will receive a 'placebo' (a dummy drug that looks the same but has no active ingredient). Neither the patients nor the doctors will know who is getting which, to keep the results fair. Everyone in the study will also receive the best standard care available for this type of stroke. The study is happening in many places around the world, including the UK, to gather enough information.

Key takeaways

This study is testing a drug (rFVIIa) for bleeding strokes.
The drug aims to reduce bleeding in the brain if given very quickly.
Participants will receive either the drug or a placebo, plus standard care.
The main goal is to improve recovery six months after the stroke.
Decisions to join must be made very quickly after a stroke occurs.
The study includes patients in the UK and other countries.

Who may be eligible?

To join this study, people must be between 18 and 80 years old and have had a specific type of bleeding stroke. A crucial part of this study is that treatment must be given within two hours of the stroke starting, so decisions about joining need to be made very quickly. You'd also need to be able to give consent, or have a family member or legal representative do so, often in an emergency situation.

However, there are reasons why someone might not be able to join. For example, if the bleeding in the brain is too small or too large, or if it's caused by something else like a head injury or a problem with blood vessels that doctors already know about. People who have had certain blood clotting problems, other serious health issues like recent heart attacks or strokes, or are already taking certain medications that affect blood clotting would also not be able to take part.

Quick self-check

Are you between 18 and 80 years old?
Did your stroke involve bleeding in the brain?
Can treatment be given within 2 hours of your stroke starting?
Do you (or a legal representative) consent to emergency research?
Do you have good kidney and liver function?
Have you not had a recent heart attack, deep vein thrombosis, or other serious clotting issues?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you are able to join the study, you would be randomly chosen to receive either the study drug (rFVIIa) or a placebo (a dummy drug), which look identical. Neither you nor your doctors would know which one you are receiving. Everyone in the study will also get the usual best medical care for this type of stroke.

After receiving the treatment, you will have more brain scans, usually within 24 hours, to see how the bleeding is changing. Doctors will also check on your health and recovery at 30 days and 90 days after your stroke. The main check-up to see how you are recovering will happen after 180 days (about six months). These follow-up appointments may happen remotely, meaning you might not need to visit the hospital in person each time. The study will aim to include 860 patients over about three and a half years.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The potential benefit of this study is that the investigational drug, rFVIIa, could help reduce bleeding in the brain, potentially leading to a better recovery from your stroke. However, it's also possible the drug might not work as hoped, or it could have side effects, though the study is designed to carefully monitor for these. You will receive the best standard care regardless of whether you receive the active drug or the placebo. You are free to withdraw from the study at any time for any reason without it affecting your medical care.

Locations (88)

University of Alabama Hospital
Birmingham, United States
St. Joseph's Hospital and Medical Center
Phoenix, United States
Kaiser Permanente Baldwin Park Medical Center
Baldwin Park, United States
Mills Peninsula Medical Center
Burlingame, United States
Kaiser Permanente Downey Medical Center
Downey, United States
Kaiser Permanente Fontana Medical Center
Fontana, United States
Kaiser Permanente South Bay Medical Center
Harbor City, United States
UCSD Health La Jolla
La Jolla, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, United States
Kaiser Permanente West Los Angeles Medical Center
Los Angeles, United States
Ronald Reagan UCLA Medical Center
Los Angeles, United States
UC Irvine Medical Center,
Orange, United States

+76 more sites — see the official record for the full list.

Common questions

What is 'intracerebral haemorrhage'?

It's a type of stroke caused by bleeding directly inside your brain, not a blood clot blocking flow.

What is rFVIIa?

It's a manufactured drug that helps blood to clot. Doctors hope it can reduce bleeding in the brain if given quickly.

Why is the treatment given so quickly?

Doctors believe that starting treatment very early, within two hours, might be key to stopping the bleeding from getting worse and improving patient recovery.

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

No, neither you nor the doctors treating you will know, to make sure the study results are as fair and accurate as possible.

How long will I be involved in the study?

You'll be monitored and have check-ups for about six months after your stroke, with the main assessment at the end of this period.