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

H

Haukeland University Hospital

Status

Completed

Conditions

Hemorrhagic Shock

Treatments

Drug: Whole blood (O Rh D-neg K-neg)
Drug: Red blood cells (0Rh D-neg)
Drug: Freeze dried plasma (LyoPlas)

Study type

Observational

Funder types

Other

Identifiers

NCT02784951
2016/304/REK vest

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

72 participants in 1 patient group

Single group
Description:
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).
Treatment:
Drug: Freeze dried plasma (LyoPlas)
Drug: Red blood cells (0Rh D-neg)
Drug: Whole blood (O Rh D-neg K-neg)

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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