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

• Sponsor: Haukeland University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02784951
• Collaborator: Sykehuset Innlandet HF (Other), Oslo University Hospital (Other), Sorlandet Hospital HF (Other), St. Olavs Hospital (Other), Helse Forde (Other), Helse Stavanger HF (Other), University Hospital of North Norway (Other), Vestre Viken Hospital Trust (Other)
• Enrollment: 72
• Locations: 9
• Actual Duration (Months): 60
• Patients Per Site: 8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhagic Shock	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:

1. Are out-of-hospital transfusions associated with an increase in adverse transfusion events compared to inhospital transfusions?

2. Is out-of-hospital physician administration of plasma or blood products in exsanguinating patients feasible?

3. Are patients in need of blood product transfusion possible to identify and transfuse in the prehospital phase/environment?

4. 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 Design

• Study Type: Observational
• Actual Enrollment: 72 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. adverse transfusion reactions [24 hours]

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

2. patients included [24 hours]

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

3. units not used [24 hours]

   Fraction of prepared plasma or blood units not used.

Secondary Outcome Measures

1. Number of adverse events [24 hours]

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

2. Type of adverse events [24 hours]

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

3. number of transfusion [24 hours]

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

4. type of transfusion [24 hours]

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

5. Systolic blood pressure (SBP) [24 hours]

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

6. heart rate (HR) [24 hours]

   heart rate (HR) on scene and at admission hospital

7. Glasgow Coma Score (GCS) [24 hours]

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

8. Respiratory rate (RR) [24 hours]

   Respiratory rate (RR) on scene and at admission hospital

9. Pulse oximeter (SPO2) [24 hours]

   Pulse oximeter (SPO2) on scene and at admission hospital

10. response time (minutes) [24 hours]

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

11. 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

12. transport time (minutes) [24 hours]

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

13. Number of surgical interventions [24 hours]

    Number of surgical interventions (first 24 hrs)

14. Type of surgical interventions [24 hours]

    type of surgical interventions (first 24 hrs)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sørlandet Hospital HF	Arendal		Norway	4809
2	Haukeland University Hospital	Bergen		Norway	5021
3	Innlandet Hospital Trust	Brumunddal		Norway	2380
4	Vestre Viken Hospital Trust	Drammen		Norway	3004
5	Helse Førde	Førde		Norway	6807
6	Oslo University Hospital	Oslo		Norway	0450
7	Helse Stavanger HF	Stavanger		Norway	8100
8	University Hospital of North Norway	Tromsø		Norway	9038
9	St Olav University Hospital	Trondheim		Norway	7006

Sponsors and Collaborators

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

Investigators

• Study Director: Hanne Klausen, MD, Medical Director, Kirurgisk Serviceklinikk, Haukeland Universitetssykehus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Haukeland University Hospital
• ClinicalTrials.gov Identifier: NCT02784951
• Other Study ID Numbers: 2016/304/REK vest
• First Posted: May 27, 2016
• Last Update Posted: Jan 10, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Emergencies; Shock, Hemorrhagic

Study Results

No Results Posted as of Jan 10, 2022