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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hemorrhagic Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Red blood cells (0Rh D-neg)

Intervention Type DRUG

Fresh produced RBC

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

Intervention Type DRUG

Fresh produced WB

Freeze dried plasma (LyoPlas)

Intervention Type DRUG

(LyoPlas N-w (German Red Cross)

Interventions

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Red blood cells (0Rh D-neg)

Fresh produced RBC

Intervention Type DRUG

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

Fresh produced WB

Intervention Type DRUG

Freeze dried plasma (LyoPlas)

(LyoPlas N-w (German Red Cross)

Intervention Type DRUG

Other Intervention Names

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RBC WB FDP

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No