RecruitingPhase IIIInterventional

Tranexamic acid (and Desmopressin) for very early bleeds in the brain

A stroke caused by bleeding in the brain is a life-threatening medical emergency. When a blood vessel bursts, pooling blood puts pressure on the brain and causes damage. Tranexamic acid is an inexpensive, widely used medicine that helps blood clot during childbirth and major accidents. Researchers at the University of Nottingham want to find out if giving this medicine within hours of a stroke can stop the bleeding from spreading. Patients arriving at the emergency department with a confirmed brain bleed may be invited to take part. Half of the participants receive the trial medicine through a vein, while the other half receive a dummy saltwater injection. Everyone receives standard NHS stroke care. Researchers then contact patients six months later to see how well they have recovered. This will help doctors understand whether the treatment improves long-term quality of life.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

University of Nottingham

Enrolment target

5,500

Start

23 Mar 2022

Estimated completion

01 Aug 2027

Hyperacute primary intracerebral haemorrhage (stroke)

What is this study about?

A bleeding stroke, known medically as an intracerebral haemorrhage, occurs when a blood vessel inside the brain bursts. As blood leaks into brain tissue, it can build up quickly, causing lasting damage or disability. Right now, there are very few treatments that can stop this bleeding early on.

Tranexamic acid is an established, low-cost medicine already used around the world to treat heavy bleeding after serious injuries and during childbirth. Earlier research showed that giving this medicine shortly after a brain bleed is safe and can keep the pool of blood from getting larger. However, doctors still need to know whether it helps people make a better long-term recovery and live more independently.

Researchers worked alongside stroke survivors and carers to design this study. The patient groups stressed that surviving a stroke is crucial, but keeping one's independence and quality of life is just as important. Because true recovery takes time, this study tracks patients for six months to see how the treatment affects their daily living and general wellbeing.

Key takeaways

Tests an affordable blood-clotting medicine to stop bleeding in the brain.
Given as a single injection in the emergency department shortly after stroke symptoms begin.
Aims to reduce long-term disability and improve quality of life.
All patients continue to receive full standard NHS stroke care.
Researchers check in after six months to measure recovery.

Who may be eligible?

This trial is open to adults who arrive at the hospital with a stroke caused by bleeding in the brain, confirmed by a brain scan. For the main study, patients must receive the treatment within 4.5 hours of their stroke symptoms starting. For a related part of the trial (DASH-2), adults who regularly take blood-thinning antiplatelet medicines (like aspirin) may be eligible within 24 hours of their symptoms.

People cannot take part if their brain bleed is extremely large, if they are in a deep coma, or if doctors feel active medical treatment would not help. People who are already receiving end-of-life care are also excluded.

Patients taking certain other strong blood-thinning medications, such as warfarin or heparin injections, cannot join the main trial. Doctors will carefully check the patient's scans and medical history before deciding if taking part is suitable.

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.

Adult aged 18 or over
Had stroke symptoms start within the last 4.5 hours (or 24 hours if on antiplatelet medicine)
Hospital brain scan confirms bleeding inside the brain
Not currently on end-of-life (palliative) care
Not taking strong blood thinners such as warfarin or heparin injections

Answer every question to see your result.

What does participation involve?

Because treatment for a stroke must start immediately, patients are approached in the emergency department as soon as their brain scan confirms a bleed. If the patient agrees—or if a doctor follows emergency consent rules when a patient cannot speak—a computer randomly chooses which treatment they receive. It is like flipping a coin: half the patients get tranexamic acid, and half get a plain saltwater injection (placebo). Neither the patient nor the doctor will know which one was given.

The medicine is given once as an injection directly into a vein. After this single dose, the patient receives all their normal hospital stroke care. There are no extra hospital visits required specifically for the trial. Around six months later, the research team will contact the participant or their family to ask about their recovery, health, and daily activities.

Potential risks and benefits

Participants might benefit if the medicine stops their brain bleed from getting worse, which could lead to a better recovery, but this cannot be promised. The information gathered will also help improve stroke treatments for others in the future. Tranexamic acid can carry a small risk of seizures at very high doses, but this study uses a much lower, safer amount. Recent research has shown no extra risk of dangerous blood clots. Taking part is completely voluntary, and participants or their families can withdraw from the study at any point without affecting their NHS care.

Locations (97)

Luton & Dunstable University Hospital
Approximate
Luton, England
South West Acute Hospital
Approximate
Enniskillen, Northern Ireland
Torbay Hospital
Approximate
Torquay, England
King's College Hospital
Approximate
London, England
Morriston Hospital
Approximate
Swansea, Wales
Royal Derby Hospital
Unverified
Derby, England
Yeovil Hospital
Unverified
Yeovil, England
Royal Victoria Hospital
Unverified
Belfast, Northern Ireland
Northwick Park Hospital
Unverified
Harrow, England
Peterborough City Hospital
Unverified
Peterborough, England
Arrowe Park Hospital
Unverified
Wirral, England
Salford Royal Hospital
Unverified
Manchester, England

Common questions

What is tranexamic acid?

It is a common medicine that helps blood to clot. It is widely used to control bleeding in accidents, surgery, and childbirth.

Why must the treatment be given so quickly?

Bleeding in the brain usually spreads during the first few hours. Giving the medicine quickly offers the best chance of limiting brain damage.

What is a placebo?

A placebo is a harmless dummy treatment, like sterile saltwater, that looks identical to the real medicine. It helps researchers prove whether the actual drug works.

Will taking part change my normal stroke care?

No. The study medicine is given as a single injection alongside all the standard emergency care and rehabilitation the NHS provides.

How can I consent if I am very unwell from the stroke?

If you are unable to make a decision due to your illness, ethical rules allow doctors to speak with your family or act in your best interests to give the emergency treatment without delay.

How to find out more

Nikola Sprigg

nikola.sprigg@nottingham.ac.uk +44 (0)115 823 1778 Official trial record

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