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

Completed

• Conditions: Hemorrhagic Shock
• Interventions: Drug: Red blood cells (0Rh D-neg); Drug: Whole blood (O Rh D-neg K-neg); Drug: Freeze dried plasma (LyoPlas)

• Registration Number: NCT02784951
• Lead Sponsor: Haukeland University Hospital

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.

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-05-27
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-17
• Last Update Posted: 2022-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single group	Whole blood (O Rh D-neg K-neg)	Patients in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products, either red blood cells (RBC), freeze dried plasma (FDP) or whole blood (WB).
Single group	Red blood cells (0Rh D-neg)	Patients in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products, either red blood cells (RBC), freeze dried plasma (FDP) or whole blood (WB).
Single group	Freeze dried plasma (LyoPlas)	Patients in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products, either red blood cells (RBC), freeze dried plasma (FDP) or whole blood (WB).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Type of adverse events	24 hours	Type of adverse events (e.g. transfusion related complications or reactions (first 24 hrs))
Systolic blood pressure (SBP)	24 hours	Systolic blood pressure (SBP) on scene and at admission hospital
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
Glasgow Coma Score (GCS)	24 hours	Glasgow Coma Score (GCS) on scene and at admission hospital
Pulse oximeter (SPO2)	24 hours	Pulse oximeter (SPO2) on scene and at admission hospital
response time (minutes)	24 hours	Physician staffed emergency medical services response (in minutes) from dispatch to arrival 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)
number of transfusion	24 hours	Number of transfusions given prehospital and inhospital (first 24 hrs)
heart rate (HR)	24 hours	heart rate (HR) 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))
type of transfusion	24 hours	type of transfusions given prehospital and inhospital (first 24 hrs)
Respiratory rate (RR)	24 hours	Respiratory rate (RR) on scene and at admission hospital

Trial Locations

Locations (9)

Sørlandet Hospital HF; 🇳🇴 Arendal, Norway

Innlandet Hospital Trust; 🇳🇴 Brumunddal, Norway

Vestre Viken Hospital Trust; 🇳🇴 Drammen, Norway

St Olav University Hospital; 🇳🇴 Trondheim, Norway

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Helse Førde; 🇳🇴 Førde, Norway

Oslo University Hospital; 🇳🇴 Oslo, Norway

University Hospital of North Norway; 🇳🇴 Tromsø, Norway

Helse Stavanger HF; 🇳🇴 Stavanger, Norway