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Completed

NCT Number: NCT02784951

Use of Blood and Plasma in Norwegian Physician-staffed Helicopter Emergency Medical System

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.

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Key information

Conditions

Hemorrhagic Shock Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Hemorrhagic

Sex eligibility

All sexes

Study type

Observational

Primary location

Sørlandet Hospital HF, Arendal, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Red blood cells (0Rh D-neg)

Drug

Fresh produced RBC

Other names: RBC

Whole blood (O Rh D-neg K-neg)

Drug

Fresh produced WB

Other names: WB

Freeze dried plasma (LyoPlas)

Drug

(LyoPlas N-w (German Red Cross)

Other names: FDP

Primary outcomes

  1. adverse transfusion reactions

    Time frame: 24 hours

    Fraction of patients with suspected adverse transfusion reactions after administration of plasma and/or blood products.

  2. patients included

    Time frame: 24 hours

    Fraction of patients fulfilling inclusion criteria with prehospital administration of blood products

  3. units not used

    Time frame: 24 hours

    Fraction of prepared plasma or blood units not used.

Secondary outcomes

  1. Number of adverse events

    Time frame: 24 hours

    Number of adverse events (e.g. transfusion related complications or reactions (first 24 hrs))

  2. Type of adverse events

    Time frame: 24 hours

    Type of adverse events (e.g. transfusion related complications or reactions (first 24 hrs))

  3. number of transfusion

    Time frame: 24 hours

    Number of transfusions given prehospital and inhospital (first 24 hrs)

  4. type of transfusion

    Time frame: 24 hours

    type of transfusions given prehospital and inhospital (first 24 hrs)

  5. Systolic blood pressure (SBP)

    Time frame: 24 hours

    Systolic blood pressure (SBP) on scene and at admission hospital

  6. heart rate (HR)

    Time frame: 24 hours

    heart rate (HR) on scene and at admission hospital

  7. Glasgow Coma Score (GCS)

    Time frame: 24 hours

    Glasgow Coma Score (GCS) on scene and at admission hospital

  8. Respiratory rate (RR)

    Time frame: 24 hours

    Respiratory rate (RR) on scene and at admission hospital

  9. Pulse oximeter (SPO2)

    Time frame: 24 hours

    Pulse oximeter (SPO2) on scene and at admission hospital

  10. response time (minutes)

    Time frame: 24 hours

    Physician staffed emergency medical services response (in minutes) from dispatch to arrival on-scene

  11. on-scene time (minutes)

    Time frame: 24 hours

    Time (in minutes) from emergency medical services arrival on-scene until patients leaves the scene or is pronounced dead on-scene

  12. transport time (minutes)

    Time frame: 24 hours

    Time (in minutes) from the patients leaves the scene until patient arrives in hospital

  13. Number of surgical interventions

    Time frame: 24 hours

    Number of surgical interventions (first 24 hrs)

  14. Type of surgical interventions

    Time frame: 24 hours

    type of surgical interventions (first 24 hrs)

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Helse Forde
  • Helse Stavanger HF
  • Oslo University Hospital
  • Sorlandet Hospital HF
  • St. Olavs Hospital
  • Sykehuset Innlandet HF
  • University Hospital of North Norway
  • Vestre Viken Hospital Trust

Registry information

Official study 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

Acronym: ProHEMS

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 27, 2016
Registry last updated
Jan 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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