To investigate the feasibility of the implementation of a point-of-care immunological test based on blood cells of all trauma patients with the aid of an automated load-and-go flow cytometer in an acute trauma care setting at the shock room.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
trauma
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is reached if the following criteria are met:
- The Trauma surgeon (or assistant) is able to perform all the necessary
actions to start the blood analysis.
- Blood analysis was started <30 min after patient arrival in the trauma room.
- Interpretable data of neutrophil flow cytometry is saved on the attached
computer.
Secondary outcome
The secondary endpoint is defined as a difference in neutrophil phenotype
and/or response between the patients that develop infectious complications and
non-infectious trauma patients.
Background summary
The functional phenotype (decreased responsiveness) of circulating neutrophils
(white blood cells) proved an adequate measurement of the amplitude of the
immunological response after trauma. The (in)ability of neutrophils to respond
to bacterial stimuli (fMLF) directly after trauma (day 0) was related to the
development of infectious complications, such as septic shock (>day 5).
Infectious complications are heterogeneous in their presentation and require
both local, host and environmental factors. The incidence of the most severe
infectious complications decreased the past decade. Therefore, analysis of
infections after injury has become even more complex and a large sample size is
required to also include patients that will develop the most severe infectious
complications. Until now, such a large study was not possible, as the analysis
of differences in the functional phenotype of neutrophils was normally carried
out by classical flowcytometry. This is time consuming, labor intensive and
sensitive for human error. This is the reason why our previous discovery has
not been implemented the daily clinical setting yet. However, analysis of
neutrophil functionality can now 24/7 be performed automatically by a fully
automated point-of-care flowcytometer (AQUIOS). Our study group adjusted and
tested this machine in a controlled laboratory environment with a dedicated
researcher measuring blood samples of healthy controls. This current
implementation study investigates whether the AQUIOS can be implemented in a
hectic clinical setting associated with the care of trauma patients. This will
serve as a step-up to a large multicenter, international prognostic study for
detecting and predicting infectious complications in trauma patients.
Study objective
To investigate the feasibility of the implementation of a point-of-care
immunological test based on blood cells of all trauma patients with the aid of
an automated load-and-go flow cytometer in an acute trauma care setting at the
shock room.
Study design
A prospective study
Study burden and risks
A total of 4 milliliter blood will be collected from the patient once upon
presentation in the trauma resuscitation bay in the emergency department. This
will be combined with regular diagnostic blood sampling in order that no extra
puncture is necessary. Sampling of this amount of blood will not diminish the
total volume of circulating blood in the vasculature of these patients and the
additional risk for clinical signs and symptoms due to anemia is non-present.
The patients participating in this study will not benefit of this measurement.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
All trauma patients presented at the trauma bay in the emergency department of the UMCU, that need to undergo blood sampeling. Age must be at least 18.
Exclusion criteria
Patient transferred from other hospitals to the UMC Utrecht.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL64100.041.17 |