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

NCT02784951 | Completed DMC

• 1 other identifier: 2016/304/REK vest
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 9

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.

Conditions

Hemorrhagic Shock

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (14)

• Number of adverse events

  24 hours

• Type of adverse events

  24 hours

• number of transfusion

  24 hours

• type of transfusion

  24 hours

• Systolic blood pressure (SBP)

  24 hours

Study Arms (1)

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); Drug: Whole blood (O Rh D-neg K-neg); Drug: Freeze dried plasma (LyoPlas)

Interventions

Red blood cells (0Rh D-neg) DRUG

Fresh produced RBC

Also known as: RBC

Single group

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

Fresh produced WB

Also known as: WB

Single group

Freeze dried plasma (LyoPlas) DRUG

(LyoPlas N-w (German Red Cross)

Also known as: FDP

Single group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients with known previous serious allergic reactions to blood product transfusions
• Patients who refuse blood products on religious grounds, e.g. Jehovah´s Witness

Sponsors & Collaborators

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

Study Sites (9)

Sørlandet Hospital HF

Arendal, 4809, Norway

Location

Haukeland University Hospital

Bergen, 5021, Norway

Location

Innlandet Hospital Trust

Brumunddal, 2380, Norway

Location

Vestre Viken Hospital Trust

Drammen, 3004, Norway

Location

Helse Førde

Førde, 6807, Norway

Location

Oslo University Hospital

Oslo, 0450, Norway

Location

Helse Stavanger HF

Stavanger, 8100, Norway

Location

University Hospital of North Norway

Tromsø, 9038, Norway

Location

St Olav University Hospital

Trondheim, 7006, Norway

Location

Related Publications (1)

• Sunde GA, Bjerkvig C, Bekkevold M, Kristoffersen EK, Strandenes G, Bruserud O, Apelseth TO, Heltne JK. Implementation of a low-titre whole blood transfusion program in a civilian helicopter emergency medical service. Scand J Trauma Resusc Emerg Med. 2022 Dec 9;30(1):65. doi: 10.1186/s13049-022-01051-z.

  PMID: 36494743 DERIVED

MeSH Terms

Conditions

Shock, Hemorrhagic

Interventions

Erythrocyte Count; formycin diphosphate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Hanne Klausen, MD

  Medical Director, Kirurgisk Serviceklinikk, Haukeland Universitetssykehus

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 27, 2016
• Study Start: January 1, 2016
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 10, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (9)