Mortality of hemorrhagic shock grade 2 and 3 is from 50 to '80% in the first 24 hours, and morbidity and mortality betrayed is to 7 to 8 days of' 90% for Acute Respiratory Distress Syndrome and / or Multiple Organ Failure. Survival percentage is inversely proportional to the time where you can intervene (1 hour / 10% - the Golden Hour) MedDRA version: 14.1 Level: PT Classification code 10049771 Term: Shock haemorrhagic System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Product Name: Tetracosactide
Product Code: NA
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: TETRACOSACTIDE
CAS Number: 16960-16-0
Current Sponsor code: ACTH 1
Sponsors
HEALTH RICERCAE SVILUPPO SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients of both sexes in hemorrhagic shock grade 2 and 3 (or Level III and IV) to be treated at pre-or intra-hospital filed Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: 1. Poisonings, hangings, drownings and asphyxiations; 2. Any patient attended at the incident scene by a non-BASICS doctor and where the intravenous fluids protocol of the attending paramedic will be recorded as having been overridden by that doctor; 3. Patients dead at the scene before the ambulance arrived and who remained without vital signs for the duration of the prehospital phase of care; 4. Patients with superficial skin injuries, including simple penetrating injuries. 5. Any patient with burns; 6. Any patient whose trauma diagnosis on admission will be an isolated fractured neck of femur or single pubic rami fracture, whether or not they died; 7. Patients whose trauma diagnosis on admission will be an isolated simple facial injury, including simple eye injuries; 8. Patients whose trauma diagnosis on admission will be a simple spinal sprain (i.e. acute cervical, thoracic or lumbar sprain with no fracture or dislocation). 9. Patients involved in major incidents', as not defined by each individual ambulance service; 10. Any trauma patient aged or apparently aged less than 18 years; 11. Any female trauma patient known to be or apparently pregnant; 12. Any patient attended by a crew that had only an emergency medical technician or a paramedic qualified for less than 1 year and not randomly allocated to a treatment branch.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Treatment of a life-saving kit casualties in hemorrhagic shock: a)reduction in mortality from hemorrhagic shock of grade 2 or 3 from 50 to 80% in the first 24 hours; b)reduction of morbidity and mortality betrayed to 7 - 8 days of '90% for Acute Respiratory Distress Syndrome and/or Multiple Organ Failure;Secondary Objective: Adjunct of the individual treatment of hemorrhagic shock in the pre-and intra-hospital emergencies and Critical Mass Events by war or natural cause also with self injector devices.;Primary end point(s): Validation of tetracosactide dose of 10 mg as an important adjunct in the treatment of shock grade 2 and 3 as support for pre-and intra hospital emergencies;Timepoint(s) of evaluation of this end point: Significant reduction of plasma specific biological components of hemorrhagic shock when initiating the process of stabilization (T0_T24 hours) using the following plasma assays: TNF alpha, TNF beta, IL6, IL10; IFgamma; VEGF, Flt3 ligand, fractalkine, PDGF; selectin; sICAM-1; sVCMA-1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Validation of treatment with ACTh 1-24 for resuscitation and stabilization of the victim in hemorrhagic shock after trauma / surgical bleeding on the field or on scene, in pre and in hospital emergencies, particularly in the critical mass events (acts of terrorism, war, disasters, etc..) that involved in a brief window of time high-volume emergency services and limited land resources.;Timepoint(s) of evaluation of this end point: Analysis of the relationship between scores on international standards for mortality and morbidity expected and that observed in relation to the clinical condition of the patient in shock and the treatment received: logistic EuroSCORE, Intensive Care Unit score, APAHCE II. All patients will be classified with the data base of SDO and Procedures SDO ICD9 CM | — |
Countries
Italy
Contacts
Public ContactHR&S - CTS SMD L 023
Health Ricerca e Sviluppo Spin off University of Bologna
Outcome results
None listed