Cardiovascular collapse following traumatic haemorrhage
Conditions
Interventions
Trade Name: Rapiscan
Product Name: Rapiscan
Pharmaceutical Form: Injection
INN or Proposed INN: Regadenoson
CAS Number: 313348-27-5
Other descriptive name: synthetic A2A adenoreceptor agonist
Concentr
Sponsors
Queen Mary University London
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Male • Deemed to be aged =18 and =70 years • Activated pre-hospital code-red criteria (activation criteria are: systolic blood pressure =65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: • Patient suffered a traumatic cardiac arrest prior to screening • Patients who are suspected to have shock due a non-haemorrhagic cause, as assessed by the pre-hospital care team • Time of IMP/Placebo administration not attainable prior to admission to the receiving hospital • Presence of obvious catastrophic traumatic brain injury or other non-survivable injury, diagnosed by the pre-hospital team • Known or suspected pre-injury cardiac disease • Known allergy to regadenoson
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Regadenoson is a medicine that dilates blood vessels within the muscle of the heart, and is currently used to enable doctors to visualise the blood supply to heart tissue. The drug works by stimulating a particular type of receptor found in the heart and blood vessels. In addition to dilating blood vessels and improving blood flow, this particular receptor is also thought to protect cells that are not receiving enough oxygen, such as in the case of severe bleeding following injury. Our research team have a developed an animal model that recreates severe bleeding in trauma. Using this model, we have demonstrated that Regadenoson improves the function of the heart, reduces the severity of shock (reduced blood flow), and lowers the amount of fluid needed in resuscitation. We now wish to carry out a Phase 2a study to test whether the use of Regadenoson in severely injured, bleeding trauma patients can provide similar benefits to patient outcomes. We wish to determine whether Regadenoson ;Secondary Objective: In addition to the above, we wish to explore the following: •Change in lactate from baseline to 2 hours post-dosing •h-FABP level on admission and 24 hours (+/- 12-hours) •24-hour fluid and transfusion requirements •Lactate level at admission and 24 hours post-admission •Blood pressure on admission •MAP on admission •Difference between lowest SBP PH and admission SBP •Number of ACEs (defined as rhythm or, ECG changes when noted by clinical team). •Daily SOFA score for days 1 to 7 •Daily CTCOFR for days 1 to 7 •Total number of vasopressor/inotrope days including vasopressor/inotrope type and dose up to day 28, discharge, or death •Total length of hospital stay up to day 28, discharge, or death •GOS-E at discharge •Total length of critical care stay up to day 28, discharge, or death •Mortality (2-hour, 24-hour, discharge/28-day whichever is sooner);Primary end point(s): Blood lactate level 2 hours post IMP administration.;Timepoint(s) of evaluatio | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in lactate from baseline to 2 hours post-dosing • h-FABP level on admission and 24 hours (+/- 12-hours) • 24-hour fluid and transfusion requirements • Lactate level at admission and 24 hours post-admission • Blood pressure and MAP on admission • Difference between lowest SBP PH and admission SBP • Number of ACEs (defined as rhythm, ECG changes when noted by clinical team). • SOFA score for days 1 to 7 • CTCOFR for days 1 to 7 • Total number of vasopressor/inotrope days including vasopressor/inotrope type and dose • Total length of hospital stay. • GOS-E at discharge • Total length of critical care stay. • Mortality (24-hour, discharge/28-day whichever is sooner). ;Timepoint(s) of evaluation of this end point: as above | — |
Countries
United Kingdom
Contacts
Public ContactDr Mays Jawad
Queen Mary University London
Outcome results
None listed