1. Implementation of a point-of-care fully automated analysis of neutrophils in the emergency department trauma bay in monotrauma geriatric hip fracture patients. 2. To determine if patients who develop infectious complications demonstrate decreased…
ID
Source
Brief title
Condition
- Bone and joint injuries
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is reached if the AQUIOS is started <30 minutes after
blood withdraw and the flowcytometry data is saved in the computer. The study
is defined as successful if het test is rightly done in >80% of all included
patients.
Secondary outcome
The secondary endpoints are defined as
- a difference in protein expression and/or neutrophil responsiveness between
the patients that develop infectious complications and patients who do not.
- a difference in pH, PvO2, PvCO2, or HCO3- between the patients that develop
infectious complications and patients who do not.
Background summary
The functional phenotype (decreased responsiveness to fMLF) 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 late 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 responsiveness of neutrophils was normally carried out by
classic flowcytometry. This is time consuming, labor intensive and sensitive
for human error. This is the reason why our previous discovery has not been
implemented in a daily clinical care yet. However, analysis of neutrophils can
now 24/7 be performed automatically by a fully automated point-of-care
flowcytometer (AQUIOS).
Study objective
1. Implementation of a point-of-care fully automated analysis of neutrophils in
the emergency department trauma bay in monotrauma geriatric hip fracture
patients.
2. To determine if patients who develop infectious complications demonstrate
decreased neutrophil responsiveness and protein expression comparable to trauma
patients without infectious complications
3. To determine if patients who develop infectious complications demonstrate
differences in pH, PvO2, PvCO2, or HCO3- comparable to trauma patients without
infectious complications
Study design
A prospective cohort study, diagnostic research
Study burden and risks
A total of 8 milliliter blood will be collected from the patient once upon
presentation in the trauma resuscitation bay in the emergency department,
usually within the first 5 minutes after presentation. 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.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
70 years old or above
Subtrochanteric, pertrochanteric, or femoral neck fracture
Exclusion criteria
< 70 years
pathological fracture (i.e. suspect for malignancy)
Design
Recruitment
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 | NL74282.100.20 |