Evaluation of the incidence proportion and severity of bleeding in trauma patients admitted to the shockroom of the VUmc.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Traumatisch letsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The incidence proportion of bleeding in trauma patients as reflected by blood
transfusions and/or surgical- or radiological interventions to control
bleeding.
Secondary outcome
* Level of comparison of INTEM clotting time and aPTT and FIBTEM and Clauss
test for fibrinogen.
* Age, gender, length, body weight, hematocrit, hemoglobin, leukocyte count,
CRP, highest creatinine, ISS, predictive outcome scores
* Temperature upon arrival at the emergency department and temperature dynamics
over the first 24 hours post-trauma.
* Level of fibrinolysis using ROTEM APTEM test
* Tissue factor, thrombin, thrombin-antithrombin complexes (TAT), antithrombin
III (AT III), D-dimers and protein C
* Medicine use: use of drugs that influence coagulation
* Administration of blood products and fluid, urine production
Background summary
A recent meta-analysis showed that about one third of patients with trauma have
signs of coagulopathy. The presence of coagulopathy in trauma patients is
related to poor prognosis, as it may promote ischemic injury secondary to
bleeding. Moreover, coagulopathy forms a lethal triad together with hypothermia
and acidosis, which additionally advances the development of secondary injury
in trauma patients. A recent evaluation of the *Amsterdam Lifeliner: Analysis
of Results & Methods database (ALARM database) however revealed that less than
15% of our trauma patients suffer from severe bleeding. The discrepancy of our
findings with international literature may be explained by our urban patient
population and the severity of trauma. In this observational study we aim to
investigate the incidence proportion and severity of bleeding and the dynamics
in hemostasis in trauma patients. The study will further focus on the relation
of bleeding with the cause and severity of trauma, the application of
intravenous fluid therapy and cardiovascular parameters in the first 24 hours
post-trauma.
Study objective
Evaluation of the incidence proportion and severity of bleeding in trauma
patients admitted to the shockroom of the VUmc.
Study design
Prospective, observational study in 120 trauma patients.
Study burden and risks
The burden associated with participation consists of extra blood sampling (52.5
ml) from an existing intravenous line which is present in all trauma patients.
Drawing of these blood samples is associated with a minimal risk for the
patient.
De Boelelaan 1117
1081 HV
NL
De Boelelaan 1117
1081 HV
NL
Listed location countries
Age
Inclusion criteria
Trauma patients treated by a trauma team that received medical care in the shock room
Age > 18 years
Exclusion criteria
Patients with haemostatic abnormalities or deficiencies
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 | NL28908.029.09 |