RecruitingPhase IIInterventional

Investigating whether regadenoson is safe and can improve patient outcomes following severe injury and bleeding

When a person suffers a major accident and loses a lot of blood, their organs can quickly become starved of oxygen. This medical emergency is known as shock. This Phase II clinical trial is investigating whether a single injection of a medicine called regadenoson can help protect the heart and reduce bodily stress after severe blood loss. The trial involves men aged 18 to 70 who are treated by London’s Air Ambulance for life-threatening injuries and need urgent blood transfusions. Participants are randomly chosen to receive either standard emergency care alone or standard care plus one dose of regadenoson at the scene. Once transferred to a major trauma centre, patients are monitored for up to 28 days, with blood tests taken in the first week to check heart health and treatment safety.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

Queen Mary University of London

Enrolment target

Start

01 Aug 2020

Estimated completion

31 Jan 2027

Critical injury and signs of haemorrhagic shock

What is this study about?

When someone is severely injured and loses a large amount of blood, their blood pressure drops to dangerous levels. This condition, called haemorrhagic shock, starves vital organs of oxygen and puts immense strain on the heart. Even with rapid blood transfusions, the damage caused by sudden blood loss can lead to long-term health problems or death. Finding ways to protect the heart and vital organs in the first hour after an accident is crucial.

This trial investigates a drug called regadenoson. In earlier laboratory studies, giving this drug soon after heavy bleeding helped protect heart muscle, lowered stress on body cells, and reduced the total amount of fluid transfusions needed. Researchers want to find out whether giving this medication immediately at the scene of an injury can achieve the same protective results in humans.

Because every minute matters in severe trauma, the treatment is given directly by London's Air Ambulance doctors before the patient reaches the hospital. By finding out whether regadenoson is safe and effective in real-world emergencies, this study could lead to better emergency treatments for critically injured patients across the UK and worldwide.

Key takeaways

Tests whether the drug regadenoson can protect the heart after major blood loss.
Given as a single injection at the scene of the injury by London's Air Ambulance.
Open to men aged 18 to 70 suffering from severe, bleeding-related trauma.
Participants receive full standard emergency care alongside hospital monitoring for up to 28 days.
Care is closely supervised by trained trauma and emergency doctors at all times.

Who may be eligible?

This trial is specifically for adult men aged between 18 and 70 who have suffered a sudden, major physical injury and are being treated by London's Air Ambulance. To take part, the patient must have dangerously low blood pressure due to heavy bleeding, need an urgent blood transfusion at the scene, and require a breathing tube.

Because this is an emergency study testing a time-sensitive medicine, treatment must begin within one hour of the air ambulance doctor arriving. Patients cannot join if their injury is clearly not survivable, if they have suffered a cardiac arrest before the doctor arrives, or if their shock is caused by something other than bleeding.

Men who have known heart problems prior to the injury or known allergies to regadenoson are also excluded to protect their safety.

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.

Is a male aged between 18 and 70 years old
Has suffered a sudden, major physical injury
Has life-threatening bleeding requiring an emergency blood transfusion
Needs breathing support with a ventilator
Has no known history of heart disease before the accident

Answer every question to see your result.

What does participation involve?

Because this study takes place during a life-threatening emergency, the medicine is given immediately at the scene by the air ambulance team. Participants are randomly placed into one of two groups: one group receives standard emergency care, while the other group receives standard care plus a single injection of regadenoson.

After receiving emergency treatment, the patient is taken directly to one of London's major trauma hospitals. While recovering in hospital, research staff monitor the patient's heart function and overall health for up to 28 days. Small blood samples are taken during the first seven days to check how the heart is coping and to test for any side effects. There are no extra hospital visits required after discharge.

Potential risks and benefits

Participants might benefit from improved heart protection and a better recovery from severe bleeding, though these benefits cannot be guaranteed. The study also helps doctors discover better ways to save trauma victims in the future. Regadenoson can cause short-term side effects, including facial flushing, dizziness, feeling sick, chest discomfort, or breathlessness. Less commonly, it may cause low blood pressure or irregular heartbeats, and in very rare cases, a stroke. Because the drug is given by emergency doctors, any side effects will be treated immediately. Participants or their families can withdraw from the study at any stage without affecting their normal medical care.

Locations (4)

The Royal London Hospital
Approximate
London, England
St Mary's Hospital
Approximate
London, England
St George's Hospital
Approximate
London, England
King's College Hospital
Approximate
London, England

Common questions

Why is this trial only open to men?

Early clinical studies often limit initial testing to one group to reduce biological differences and ensure clear safety results. If the medicine proves safe and helpful, future trials are likely to include women as well.

How can a patient agree to join if they are unconscious?

In life-threatening situations where a person cannot give consent, UK law allows emergency treatments to be given under strict ethical rules. The medical team will inform the patient or their family as soon as possible, and they can choose to leave the study at any time.

Will taking part delay emergency transport to the hospital?

No. The trial injection is given quickly at the scene alongside routine life-saving procedures. It will not delay travel to the trauma centre.

What is regadenoson normally used for?

Regadenoson is already an approved medicine used in hospitals during heart scans to temporarily increase blood flow to the heart.

Does the patient still receive normal trauma care?

Yes. Every participant receives the full, standard emergency care, including blood transfusions, breathing support, and emergency surgery if needed.

How to find out more

Karim Brohi

k.brohi@qmul.ac.uk +44 (0)2078 826175 Official trial record

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