Critical injury and signs of haemorrhagic shock Injury, Occupational Diseases, Poisoning
Conditions
Interventions
The researchers wish to carry out a Phase 2a study aimed at testing the safety and potential effectiveness of regadenoson in a randomised controlled trial in the adult trauma-haemorrhage population.
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male 2. Deemed to be aged =18 and =70 years 3. Activated pre-hospital code-red criteria (activation criteria are: systolic blood pressure <90 mmHg AND suspected haemorrhage) 4. Started transfusion of at least 1 unit of packed red blood cells (PRBCs) (or blood component equivalent) 5. Is intubated and ventilated 6. Patient has suffered a traumatic injury 7. Is able to be randomised within 1 hour of the pre-hospital physician arriving at the scene of the injury
Exclusion criteria
Exclusion criteria: 1. Patient suffered a traumatic cardiac arrest prior to screening 2. Patients who are suspected to have shock due to a non-haemorrhagic cause, as assessed by the pre-hospital care team 3. Unable to administer IMP within pre-hospital phase of care 4. Presence of obvious catastrophic traumatic brain injury or other non-survivable injury, suspected by the pre-hospital team 5. Known or suspected pre-injury cardiac disease 6. Known allergy to Regadenoson
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Shock (lack of blood flow to the body’s tissues) measured by collection of a blood sample and measurement of lactate (a shock biomarker) at 2 hours post IMP administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in lactate (a marker of lack of blood flow to the tissues) measured using blood sample following admission to hospital to 2 hours after the intervention 2. Measurement of damage to the heart muscle after the intervention through measurement of h-FABP, a protein released by damaged heart muscle, measured using blood sample on admission and 24 hours after the intervention 3. Amount of fluid transfused to the patient recorded in medical notes within 24 hours of the intervention 4. Lactate measured using blood sample on hospital admission and at 24 hours after admission 5. Blood pressure recorded by the patient's clinical team in medical notes on admission to hospital 6. Mean arterial blood pressure recorded by the patient's clinical team in medical notes on admission to hospital 7. Difference between lowest systolic blood pressure recorded by the patient's clinical team in medical notes before hospital admission and at hospital admission 8. Number of adverse cardiac events: abnormal heart episodes defined as rhythm or ECG changes recorded by the patient's clinical team in medical notes during hospital stay 9. How the patient's organs are performing, measured using the Sequential Organ Failure Assessment score and composite time to complete organ failure recovery, for 7 days 10. The total number of days the patient receives drugs that support the hearts function (vasopressor/inotrope) including the type and dose recorded in medical notes for a maximum of 28 days 11. Total length of hospital stay recorded in medical notes for a maximum of 28 days 12. Scoring of the patient's health outcome using the GOS-E at discharge, day 28 or death - whichever is soonest 13. Total length of critical care stay recorded in medical notes for a maximum of 28 days 14. Survival status recorded in medical notes up to 28 days | — |
Countries
England, United Kingdom
Outcome results
None listed