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

Hemorrhagic Shock Clinical Trial

— ProHEMS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784951
• Other study ID #: 2016/304/REK vest
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2021
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Hemorrhagic Shock
• Shock, Hemorrhagic

Intervention

Drug:
• Red blood cells (0Rh D-neg)
Fresh produced RBC
• Whole blood (O Rh D-neg K-neg)
Fresh produced WB
• Freeze dried plasma (LyoPlas)
(LyoPlas N-w (German Red Cross)

Locations

Country	Name	City	State
Norway	Sørlandet Hospital HF	Arendal
Norway	Haukeland University Hospital	Bergen
Norway	Innlandet Hospital Trust	Brumunddal
Norway	Vestre Viken Hospital Trust	Drammen
Norway	Helse Førde	Førde
Norway	Oslo University Hospital	Oslo
Norway	Helse Stavanger HF	Stavanger
Norway	University Hospital of North Norway	Tromsø
Norway	St Olav University Hospital	Trondheim

Sponsors (9)

Lead Sponsor	Collaborator
Haukeland University Hospital	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

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse transfusion reactions	Fraction of patients with suspected adverse transfusion reactions after administration of plasma and/or blood products.	24 hours
Primary	patients included	Fraction of patients fulfilling inclusion criteria with prehospital administration of blood products	24 hours
Primary	units not used	Fraction of prepared plasma or blood units not used.	24 hours
Secondary	Number of adverse events	Number of adverse events (e.g. transfusion related complications or reactions (first 24 hrs))	24 hours
Secondary	Type of adverse events	Type of adverse events (e.g. transfusion related complications or reactions (first 24 hrs))	24 hours
Secondary	number of transfusion	Number of transfusions given prehospital and inhospital (first 24 hrs)	24 hours
Secondary	type of transfusion	type of transfusions given prehospital and inhospital (first 24 hrs)	24 hours
Secondary	Systolic blood pressure (SBP)	Systolic blood pressure (SBP) on scene and at admission hospital	24 hours
Secondary	heart rate (HR)	heart rate (HR) on scene and at admission hospital	24 hours
Secondary	Glasgow Coma Score (GCS)	Glasgow Coma Score (GCS) on scene and at admission hospital	24 hours
Secondary	Respiratory rate (RR)	Respiratory rate (RR) on scene and at admission hospital	24 hours
Secondary	Pulse oximeter (SPO2)	Pulse oximeter (SPO2) on scene and at admission hospital	24 hours
Secondary	response time (minutes)	Physician staffed emergency medical services response (in minutes) from dispatch to arrival on-scene	24 hours
Secondary	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
Secondary	transport time (minutes)	Time (in minutes) from the patients leaves the scene until patient arrives in hospital	24 hours
Secondary	Number of surgical interventions	Number of surgical interventions (first 24 hrs)	24 hours
Secondary	Type of surgical interventions	type of surgical interventions (first 24 hrs)	24 hours