The aim of this study is twofold: 1) to measure ROTEM profiles in patients at risk for DIC to determine cut off values of ROTEM corresponding to the currently used International Society for Thrombosis and Haemostasis (ISTH) DIC scores, as well as to…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
ROTEM value corresponding to DIC
Secondary outcome
level of damage molecules and other proteins that contribute to the
pathophysiology of DIC
specific clinical risk factors for bleeding and thrombosis in DIC
Background summary
Disseminated intravascular coagulation (DIC) is a devastating complication of
critical illness and an independent predictor of organ failure and mortality.
Thereby, patients are at risk for both bleeding and thromboembolic events.
Current diagnostics do not predict the risk for thrombosis or bleeding and
hence cannot discriminate which patients would benefit or harm from an
anticoagulant strategy.
Rotational thromboelastometry (ROTEM) can both detect a hypo- and
hypercoagulable profile and therefore may have the potential to diagnose both
DIC as well as predict risks of bleeding an thrombosis in patients at risk for
DIC. Besides the limited knowledge on individual risk factors for bleeding or
thrombosis, the exact pathophysiology of DIC also remains unknown. Experimental
data suggest that fibrinogen may protect against DIC by binding histones, but
clinical data are scarce.
Study objective
The aim of this study is twofold: 1) to measure ROTEM profiles in patients at
risk for DIC to determine cut off values of ROTEM corresponding to the
currently used International Society for Thrombosis and Haemostasis (ISTH) DIC
scores, as well as to bleeding and thromboembolic events. 2) to measure
histones and other parameters of the DIC coagulation cascade to improve insight
in the pathophysiology
Study design
Multi center observational cohort study
Study burden and risks
The burden and risk associated with participation are negligible. A single
blood sample will be obtained from the arterial line whichis already in place
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Patients admitted to the ICU who have a risk factor for DIC (infection,
obstetric complication, malignancy, trauma, liver disease, pancreatitis)
Exclusion criteria
no informed consent
active bleeding
no arterial catheter in place
Design
Recruitment
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
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 | NL73336.018.20 |