The following questions will be answered:• Can typical protein-profiles in a proteomic-assay be identified after trauma, which might be correlated with the outcome of the patients?• How is the dynamic of protein-profile-changes in the proteomics-…
ID
Source
Brief title
Condition
- Bone and joint injuries
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proteomic-profile after isolated ankle-fracture on day 0 (day of trauma) and
day 1, 3, 5, 7, 14, 21, 28, 3 months after trauma.
Secondary outcome
none
Background summary
After severe trauma serious haemorrhage, severe head trauma and multiple organ
failure are still the most important causes of death. Especially in patients
with a combination of severe haemorrhage or head trauma and extremity-lesions
the question of optimal timing of the operation as well as the choice of type
of fracture stabilization is still un-answered. The key-point in this issue is
the amount of trauma-load of a patient and the possibility to tolerate a
*second-hit* like operations. The search for prognostic and determinant factors
for estimating outcome of a trauma-victim in the last years was very intensive.
The complexity of the systemic acute phase reaction to trauma might be the
reason why *the golden bullet* couldn*t be found yet. Proteomics might be a
tool to answer these unsolved questions.
Study objective
The following questions will be answered:
• Can typical protein-profiles in a proteomic-assay be identified after trauma,
which might be correlated with the outcome of the patients?
• How is the dynamic of protein-profile-changes in the proteomics-essay in the
healing-process?
Study design
We will include all adult patients with an isolated ankle-fracture.
Exclusion-criteria*s beside age are relevant co-morbidities and defeating of
the study. So we want to include patients with an ASA-classification of 1 or 2.
We want to include 20 patients.
For getting a good dynamic of the protein-profiles a continuous collecting of
blood-samples is extremely important.
The following time points for blood-sampling are planned:
Day 0 (day of trauma)
Day 1, 3, 5, 7, 14, 21, 28, 3 months.
All samples will be taken round about 11 o*clock.
The blood-samples are taken immediately to the CHIC (surgical intensive care)
were centrifuge is available. By a temperature of 4°C and with 2500 rpm the
test tubes will be centrifuged for 10 minutes. Afterwards the serum will be
divided in several eppendorff-tubes and placed in the freezer by -70°C. All
tubes will be marked following the prepared code-numbers. The first character
of the code represents the patient-number and the second the number of the
probe.
The proteomics are measured by the Groninger proteomics-lab. The results will
be correlated with the outcome and healing process of the patients.
Therefore the information*s of the patient-dossier are needed.
Study burden and risks
Very low risk for the patients. There is only a punctering of the cubital vein
necessary.
Hanzeplein 1
9700RB Groningen
Nederland
Hanzeplein 1
9700RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
Older than 17 years, isolated fracture of an ankle, accordance with the study, ASA 1 and 2
Exclusion criteria
Pat. refuses to join, ASA > 2, multiple injury
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 | NL13000.042.06 |