The goal of this pilot study is to collect data about basal values and variations in these values of the damage markers FABP, Myoglobin, CK and CRP of people with a low complete spinal cord injury. This pilot study is a preparation for a large…
ID
Source
Brief title
Condition
- Other condition
- Spinal cord and nerve root disorders
Synonym
Health condition
decubitus
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Basal values of the markers Fatty Acid Binding Protein (FABP), Myoglobine,
C-Reactive Protein (CRP) and Creatine Kinase (CK) of people with a low complete
spinal cord injury. In addition day-to-day and within-day variations of these
values.
Secondary outcome
nvt
Background summary
The aim of the project is early detection and evaluation of deep pressure
ulcers. People with a spinal cord injury have an increased risk for these
ulcers because of 1) absent or reduced sensibility, 2) continuous high
pressure, 3) bad perfusion and 4) atrophy. Deep pressure ulcers initiate in the
muscle layer adjacent to bony prominences. They become visible when they reach
the skin layer, and at that time prompt healing is impossible. The hypothesis
is that by measuring markers of skeletal muscle damage, damage can be detected
in an early stage. A change in the levels of these markers is an indication for
further examination in a more detailed manner.
Study objective
The goal of this pilot study is to collect data about basal values and
variations in these values of the damage markers FABP, Myoglobin, CK and CRP of
people with a low complete spinal cord injury. This pilot study is a
preparation for a large prospective study in which we want to study a method
for early detection of deep pressure ulcers based on the measurement of damage
markers in blood. Data on basal levels and variations is essential for the
design of such a study.
Study design
We will take blood samples at 5 consecutive days at the same time point of
people with a low complete spinal cord injury, to measure the day-to-day
variation. We will also do this measurement with a control group (people
without a spinal cord injury). In addition, we will measure the within-day
variation in the group people with a spinal cord injury in the rehabilitation
centre and the reference group. We will measure in the morning, afternoon and
at the end of the afternoon.
Study burden and risks
The risks are limited. Bloodsamples will be taken at 5 or 8 time points.
Bloodsamples will be taken by a nurse Ron Hongens, a competent, experienced and
licensed nurse of SRL (group I,II and III) or the competent, experienced and
licensed laboratory technician Carolien Menting, from Maxima Medisch Centrum
Eindhoven (group IV).
Zanbergsweg 111
6432 CC Hoensbroeck
Nederland
Zanbergsweg 111
6432 CC Hoensbroeck
Nederland
Listed location countries
Age
Inclusion criteria
Group I and II:
Age>= 18 jaar;
• ASIA-A classification, conus-cauda laesie, laesie T12 and lower ;
• At least 9 months post injury;
• Temperature < 38 oC;
• No sickness
• No pressure ulcer for at least 4 months;Group III:
same criteria as for group I and II,
except in this group people do have a pressure ulcer;Group IV (reference group):
• Age >= 18 jaar, matched with group II;
• Temperature < 38 oC;
• No sickness
Exclusion criteria
-
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL26073.022.08 |