Hemorrhagic Shock
Conditions
Brief summary
The main objective of this study is to evaluate the use of RBC, FDP, WB in the treatment of exsanguinating patients by physician-staffed emergency medical services in Norway, with focus on prehospital transfusion complications and safety.
Detailed description
This study evaluates prehospital transfusion therapy in exsanguinating patients treated by physician-staffed emergency medical services in Norway, with the following main questions: I. Are out-of-hospital transfusions associated with an increase in adverse transfusion events compared to inhospital transfusions? II. Is out-of-hospital physician administration of plasma or blood products in exsanguinating patients feasible? III. Are patients in need of blood product transfusion possible to identify and transfuse in the prehospital phase/environment? IV. Are out-of-hospital transfusion practices associated with increased waste of blood products? All patients in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products will be included, if they fulfill the listed criteria below: * Patients with mechanism of injury compatible with severe haemorrhage and/or haemorrhagic shock (e.g. penetrating torso injury, visible massive bleeding) * Radial pulse \> 100 beats/min or absent/weak radial pulse * Systolic blood pressure (SBP) \< 90 mmHg * Altered mental status (reduced GCS) in the absence of head injury or known intoxication Patients with known previous serious allergic reactions to blood product transfusions or patients who refuse blood products on religious grounds (e.g. Jehovah´s Witness) will be excluded.
Interventions
DRUGRed blood cells (0Rh D-neg)
Fresh produced RBC
DRUGWhole blood (O Rh D-neg K-neg)
Fresh produced WB
DRUGFreeze dried plasma (LyoPlas)
(LyoPlas N-w (German Red Cross)
Sponsors
Sykehuset Innlandet HF
Oslo University Hospital
Sorlandet Hospital HF
St. Olavs Hospital
Helse Forde
Helse Stavanger HF
University Hospital of North Norway
Vestre Viken Hospital Trust
Haukeland University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All patients in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products according to listed indicators below: * Patients with mechanism of injury compatible with severe haemorrhage and/or haemorrhagic shock (e.g. penetrating torso injury, visible massive bleeding) * Radial pulse \> 100 beats/min or absent/weak radial pulse * Systolic blood pressure (SBP) \< 90 mmHg * Altered mental status (reduced GCS) in the absence of head injury or known intoxication
Exclusion criteria
* Patients with known previous serious allergic reactions to blood product transfusions * Patients who refuse blood products on religious grounds, e.g. Jehovah´s Witness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adverse transfusion reactions | 24 hours | Fraction of patients with suspected adverse transfusion reactions after administration of plasma and/or blood products. |
| patients included | 24 hours | Fraction of patients fulfilling inclusion criteria with prehospital administration of blood products |
| units not used | 24 hours | Fraction of prepared plasma or blood units not used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| type of transfusion | 24 hours | type of transfusions given prehospital and inhospital (first 24 hrs) |
| Systolic blood pressure (SBP) | 24 hours | Systolic blood pressure (SBP) on scene and at admission hospital |
| heart rate (HR) | 24 hours | heart rate (HR) on scene and at admission hospital |
| Glasgow Coma Score (GCS) | 24 hours | Glasgow Coma Score (GCS) on scene and at admission hospital |
| Respiratory rate (RR) | 24 hours | Respiratory rate (RR) on scene and at admission hospital |
| Type of adverse events | 24 hours | Type of adverse events (e.g. transfusion related complications or reactions (first 24 hrs)) |
| response time (minutes) | 24 hours | Physician staffed emergency medical services response (in minutes) from dispatch to arrival on-scene |
| on-scene time (minutes) | 24 hours | Time (in minutes) from emergency medical services arrival on-scene until patients leaves the scene or is pronounced dead on-scene |
| transport time (minutes) | 24 hours | Time (in minutes) from the patients leaves the scene until patient arrives in hospital |
| Number of surgical interventions | 24 hours | Number of surgical interventions (first 24 hrs) |
| Type of surgical interventions | 24 hours | type of surgical interventions (first 24 hrs) |
| Pulse oximeter (SPO2) | 24 hours | Pulse oximeter (SPO2) on scene and at admission hospital |
| Number of adverse events | 24 hours | Number of adverse events (e.g. transfusion related complications or reactions (first 24 hrs)) |
| number of transfusion | 24 hours | Number of transfusions given prehospital and inhospital (first 24 hrs) |
Countries
Norway
Outcome results
None listed