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

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Norway
  • Arendal, Norway, 4809
    • Sørlandet Hospital HF
  • Bergen, Norway, 5021
    • Haukeland University Hospital
  • Brumunddal, Norway, 2380
    • Innlandet Hospital Trust
  • Drammen, Norway, 3004
    • Vestre Viken Hospital Trust
  • Førde, Norway, 6807
    • Helse Førde
  • Oslo, Norway, 0450
    • Oslo University Hospital
  • Stavanger, Norway, 8100
    • Helse Stavanger HF
  • Tromsø, Norway, 9038
    • University Hospital of North Norway
  • Trondheim, Norway, 7006
    • St Olav University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single group; 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).	Drug: Red blood cells (0Rh D-neg); Fresh produced RBC; Other Names: RBC; Drug: Whole blood (O Rh D-neg K-neg); Fresh produced WB; Other Names: WB; Drug: Freeze dried plasma (LyoPlas); (LyoPlas N-w (German Red Cross); Other Names: FDP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse transfusion reactions	Fraction of patients with suspected adverse transfusion reactions after administration of plasma and/or blood products.	24 hours
patients included	Fraction of patients fulfilling inclusion criteria with prehospital administration of blood products	24 hours
units not used	Fraction of prepared plasma or blood units not used.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events	Number of adverse events (e.g. transfusion related complications or reactions (first 24 hrs))	24 hours
Type of adverse events	Type of adverse events (e.g. transfusion related complications or reactions (first 24 hrs))	24 hours
number of transfusion	Number of transfusions given prehospital and inhospital (first 24 hrs)	24 hours
type of transfusion	type of transfusions given prehospital and inhospital (first 24 hrs)	24 hours
Systolic blood pressure (SBP)	Systolic blood pressure (SBP) on scene and at admission hospital	24 hours
heart rate (HR)	heart rate (HR) on scene and at admission hospital	24 hours
Glasgow Coma Score (GCS)	Glasgow Coma Score (GCS) on scene and at admission hospital	24 hours
Respiratory rate (RR)	Respiratory rate (RR) on scene and at admission hospital	24 hours
Pulse oximeter (SPO2)	Pulse oximeter (SPO2) on scene and at admission hospital	24 hours
response time (minutes)	Physician staffed emergency medical services response (in minutes) from dispatch to arrival on-scene	24 hours
on-scene time (minutes)	Time (in minutes) from emergency medical services arrival on-scene until patients leaves the scene or is pronounced dead on-scene	24 hours
transport time (minutes)	Time (in minutes) from the patients leaves the scene until patient arrives in hospital	24 hours
Number of surgical interventions	Number of surgical interventions (first 24 hrs)	24 hours
Type of surgical interventions	type of surgical interventions (first 24 hrs)	24 hours

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: Vestre Viken Hospital Trust; Oslo University Hospital; University Hospital of North Norway; Helse Stavanger HF; Sorlandet Hospital HF; St. Olavs Hospital; Sykehuset Innlandet HF; Helse Forde
• Investigators: Study Director: Hanne Klausen, MD, Medical Director, Kirurgisk Serviceklinikk, Haukeland Universitetssykehus

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: May 18, 2016
• First Submitted That Met QC Criteria: May 26, 2016
• First Posted (Estimate): May 27, 2016

Study Record Updates

• Last Update Posted (Actual): January 10, 2022
• Last Update Submitted That Met QC Criteria: December 17, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Hemorrhage; Shock; Emergencies; Shock, Hemorrhagic
• Other Study ID Numbers: 2016/304/REK vest

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No