Clinical trial NCT02784951: Use of Blood and Plasma in Norwegian Physician-staffed Helicopter Emergency Medical System
Official title: Use of Blood and Plasma in Prehospital Haemorrhagic Shock - a Prospective, Observational Trial of Advanced Deployment of Blood Products in Norwegian Physician-staffed Helicopter Emergency Medical System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhagic Shock
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Sykehuset Innlandet HF
name: Oslo University Hospital
name: Sorlandet Hospital HF
name: St. Olavs Hospital
name: Helse Forde
name: Helse Stavanger HF
name: University Hospital of North Norway
name: Vestre Viken Hospital Trust
First posted: 2016-05-27
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients (pediatric and adult) in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products by treating physician staffed emergency medical services.

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.

Eligibility criteria: 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

Primary outcomes:
measure: adverse transfusion reactions
timeFrame: 24 hours
measure: patients included
timeFrame: 24 hours
measure: units not used
timeFrame: 24 hours
Secondary outcomes:
measure: Number of adverse events
timeFrame: 24 hours
measure: Type of adverse events
timeFrame: 24 hours
measure: number of transfusion
timeFrame: 24 hours
measure: type of transfusion
timeFrame: 24 hours
measure: Systolic blood pressure (SBP)
timeFrame: 24 hours
measure: heart rate (HR)
timeFrame: 24 hours
measure: Glasgow Coma Score (GCS)
timeFrame: 24 hours
measure: Respiratory rate (RR)
timeFrame: 24 hours
measure: Pulse oximeter (SPO2)
timeFrame: 24 hours
measure: response time (minutes)
timeFrame: 24 hours
measure: on-scene time (minutes)
timeFrame: 24 hours
measure: transport time (minutes)
timeFrame: 24 hours
measure: Number of surgical interventions
timeFrame: 24 hours
measure: Type of surgical interventions
timeFrame: 24 hours
Other outcomes:
Locations:
city: Arendal
country: Norway
facility: Sørlandet Hospital HF
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Brumunddal
country: Norway
facility: Innlandet Hospital Trust
city: Drammen
country: Norway
facility: Vestre Viken Hospital Trust
city: Førde
country: Norway
facility: Helse Førde
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Stavanger
country: Norway
facility: Helse Stavanger HF
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: St Olav University Hospital
Study officials:
affiliation: Medical Director, Kirurgisk Serviceklinikk, Haukeland Universitetssykehus
name: Hanne Klausen, MD
role: STUDY_DIRECTOR
References: