Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT02784951
Status:
COMPLETED
Last Update Posted:
2022-01-10
First Post:
2016-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Blood and Plasma in Norwegian Physician-staffed Helicopter Emergency Medical System
Sponsor:
Haukeland University Hospital
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProHEMS
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 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: