Clinical Trial: Use of Blood and Plasma in Norwegian Physician-staffed Helicopter Emergency Medical Systems

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Use of Blood and Plasma in Prehospital Haemorrhagic Shock - a Prospective, Multicenter, Observational Trial of Advanced Deployment of Blood Products in Norwegian Physician

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.

Detailed Summary:

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.

Sponsor: Haukeland University Hospital

Current Primary Outcome:

• adverse transfusion reactions [ Time Frame: 24 hours ]
  Fraction of patients with suspected adverse transfusion reactions after administration of plasma and/or blood products.
• patients included [ Time Frame: 24 hours ]
  Fraction of patients fulfilling inclusion criteria with prehospital administration of blood products
• units not used [ Time Frame: 24 hours ]
  Fraction of prepared plasma or blood units not used.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Number of adverse events [ Time Frame: 24 hours ]
  Number of adverse events (e.g. transfusion related complications or reactions (first 24 hrs))
• Type of adverse events [ Time Frame: 24 hours ]
  Type of adverse events (e.g. transfusion related complications or reactions (first 24 hrs))
• number of transfusion [ Time Frame: 24 hours ]
  Number of transfusions given prehospital and inhospital (first 24 hrs)
• type of transfusion [ Time Frame: 24 hours ]
  type of transfusions given prehospital and inhospital (first 24 hrs)
• Systolic blood pressure (SBP) [ Time Frame: 24 hours ]
  Systolic blood pressure (SBP) on scene and at admission hospital
• heart rate (HR) [ Time Frame: 24 hours ]
  heart rate (HR) on scene and at admission hospital
• Glasgow Coma Score (GCS) [ Time Frame: 24 hours ]
  Glasgow Coma Score (GCS) on scene and at admission hospital
• Respiratory rate (RR) [ Time Frame: 24 hours ]
  Respiratory rate (RR) on scene and at admission hospital
• Pulse oximeter (SPO2) [ Time Frame: 24 hours ]
  Pulse oximeter (SPO2) on scene and at admission hospital
• response time (minutes) [ Time Frame: 24 hours ]
  Physician staffed emergency medical services response (in minutes) from dispatch to arrival on-scene
• on-scene time (minutes) [ Time Frame: 24 hours ]
  Time (in minutes) from emergency medical services arrival on-scene until patients leaves the scene or is pronounced dead on-scene
• transport time (minutes) [ Time Frame: 24 hours ]
  Time (in minutes) from the patients leaves the scene until patient arrives in hospital
• Number of surgical interventions [ Time Frame: 24 hours ]
  Number of surgical interventions (first 24 hrs)
• Type of surgical interventions [ Time Frame: 24 hours ]
  type of surgical interventions (first 24 hrs)

Original Secondary Outcome:

• Number of adverse events [ Time Frame: 24 hours ]
  Number of adverse events (e.g. transfusion related complications or reactions (first 24 hrs))
• Type of adverse events [ Time Frame: 24 hours ]
  Type of adverse events (e.g. transfusion related complications or reactions (first 24 hrs))
• number of transfusion [ Time Frame: 24 hours ]
  Number of transfusions given prehospital and inhospital (first 24 hrs)
• type of transfusion [ Time Frame: 24 hours ]
  type of transfusions given prehospital and inhospital (first 24 hrs)
• Systolic blood pressure (SBP) [ Time Frame: 24 hours ]
  Systolic blood pressure (SBP) on scene and at admission hospital
• heart rate (HR) [ Time Frame: 24 hours ]
  heart rate (HR) on scene and at admission hospital
• Glascow Coma Score (GCS) [ Time Frame: 24 hours ]
  Glascow Coma Score (GCS) on scene and at admission hospital
• Respiratory rate (RR) [ Time Frame: 24 hours ]
  Respiratory rate (RR) on scene and at admission hospital
• Pulsoxymetry (SPO2) [ Time Frame: 24 hours ]
  Pulsoxymetry (SPO2) on scene and at admission hospital
• response time (minutes) [ Time Frame: 24 hours ]
  Physician staffed EMSs response (in minutes) from dispatch to EMS arrival on-scene
• on-scene time (minutes) [ Time Frame: 24 hours ]
  Time (in minutes) from EMS arrival on-scene untill patients leaves the scene or is pronounced dead on-scene
• transport time (minutes) [ Time Frame: 24 hours ]
  Time (in minutes) from the patients leaves the scene untill patient arrives in hospital
• Number of surgical interventions [ Time Frame: 24 hours ]
  Number of surgical interventions (first 24 hrs)
• Type of surgical interventions [ Time Frame: 24 hours ]
  type of surgical interventions (first 24 hrs)

Information By: Haukeland University Hospital

Dates:
Date Received: May 18, 2016
Date Started: June 2016
Date Completion: May 2018
Last Updated: June 27, 2016
Last Verified: June 2016