Study to see if blood-clotting drug can help stroke patients begins at UCLH

Doctors at UCLH are investigating whether a blood‐clot promoting drug could help stop bleeding within the brain in stroke patients.

The experimental drug, called PF-05230907, could act as a huge breakthrough if it proves effective.

PF-05230907 acts on one of the body’s proteins that is part of the blood clotting system to reduce the expansion of brain haemorrhage in patients who have had a haemorrhagic stroke, which can occur when an artery inside the brain bursts.

Once doctors have confirmed a haemorrhagic stroke, eligible patients who agree to take part in this study will be screened in just a few hours as any potential treatment needs to be administered with as little delay as possible. 

Professor David Werring, Consultant Neurologist at the National Hospital for Neurology and Neurosurgery, who is leading the trial, said: “When there is a bleed into the brain (intracerebral haemorrhage) the surrounding tissues are damaged as the blood clot expands, usually within just the first few hours. We know that this expansion of the haemorrhage is a strong predictor of survival and recovery of function – so trying to limit this early bleeding process as soon as possible, to protect the brain from damage, is a key goal of treatment.”

As a drug that causes blood clotting, it is possible that this treatment may cause blood clots in other parts of the circulation. As a result, patients on the trial will be monitored very carefully for signs of deep vein thrombosis in the leg veins, heart attacks or further strokes.

Professor Werring said: “This new drug is a variant of a normal human ‘clotting factor’ blood protein (factor Xa, pronounced ‘ten a’) which helps to make our blood clot to prevent bleeding. The drug is engineered to be more resistant to inactivation by enzymes in the blood than the natural clotting factor, so should be much more effective in preventing early brain bleeding.”

This part of the study will see patients given one dose of PF-05230907 via an intravenous catheter (IV) during their first day in hospital. The amount of the drug each patient receives will depend on their body weight and which group they are assigned to in the study – different doses are being tested at this stage to help determine the highest dose of PF-05230907 that is safe and tolerated in individuals with a cerebral bleed.

Retired joiner Robert Robson suffered a haemorrhagic stroke whilst visiting his daughter Hazel at her home in north London in July 2017. Robert, 76, from Northumberland, said: “I just suddenly rolled over at my daughter’s home. My wife Isabel and I were only two days in to a planned two week visit, even though I remained conscious Isabel knew something was wrong and straight away called the ambulance.”

Robert arrived at UCLH and was assessed by Professor Werring, within a few hours he consented to take part in the trial.  “I was happy to take part in research, Professor Werring and his team’s findings may change clinical practice in the future and help a lot of people”, said Robert.  

Robert was discharged five weeks after arriving in hospital and is now recovering at home in Northumberland. Robert said: “I have physio twice a week; and Isabel and I try to go for a couple of walks a day. My left hand is still swollen, but it’s an improvement as I couldn’t move it at all when I first came home in late August. The physio staff are brilliant, as were all the hospital staff during my stay at UCLH – I can’t thank them enough.”

UCLH is just one site for the trial which will be carried out in 30 different hospitals in the UK, USA, Canada, Germany, Sweden and Spain.