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ID
Source
Brief title
Health condition
Disseminated intravascular coagulation
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cut off values of parameters of coagulation profiles as determined by ROTEM (speed and degree of clot formation, degree of fibrinolysis) corresponding to an ISTH DIC score of ≥ 5 as the gold standard, DIC with bleeding, DIC with thrombotic events, bleeding and thrombotic events in critically ill patients at risk for DIC without an ISTH DIC diagnosis, and mortality.
Secondary outcome
Distinguish patients based upon ROTEM profiles that may benefit from timely anticoagulant strategies
Compare ROTEM profiles and other parameters of coagulation between patients who have DIC due to different clinical risk factors
Determine a critical fibrinogen to nucleosome ratio that corresponds to the development of DIC and thrombosis
Relate nucleosome levels to other markers of endothelial activation and coagulation
Determine specific clinical risk factors for bleeding and thrombosis in DIC
Background summary
Disseminated intravascular coagulation (DIC) is a devestating complication of critical illness and an independent predictor of organ failure and mortality. DIC is characterized by systemic vascular activation with ensuing consumption coagulopathy with microthrombi formation. Thereby, patients are at risk for both bleeding and thromboembolic events. However, specific risk factors for bleeding and thrombosis are unknown. Current diagnostics rely on conventional coagulation testing to calculate a DIC score. However, this score cannot predict the risk for thrombosis or bleeding and hence cannot discriminate which patients would benefit from an anticoagulant strategy. Rotational thromboelastometry (ROTEM) may have the potential to diagnose both DIC as well as predict risks of bleeding and thrombosis in patients at risk for DIC.
The aim of our study is twofold: 1) to measure ROTEM profiles in critically ill 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 damage associated molecular patterns (DAMPs) and other parameters of the DIC coagulation cascade to improve insight in the pathophysiology of DIC.
Study objective
ROTEM is able to detect DIC and predict which patients are at risk of bleeding or thrombosis. Furthermore, we hypothesize thromboembolic events due to DIC occur when fibrinogen drops below a certain value compared to DAMP levels.
Study design
Single blood draw between day 1 - 4 of ICU stay.
Romein Dujardin
0205666328
r.w.dujardin@amsterdamumc.nl
Romein Dujardin
0205666328
r.w.dujardin@amsterdamumc.nl
Inclusion criteria
- Critically ill patients ≥ 18 years of age with a clinical condition that is associated with a risk of developing DIC (e.g. severe infection, post-surgery severe infection, trauma, acute pancreatitis, tumors, hematologic malignancy).
- Platelet count < 150x10^9/L
Exclusion criteria
- No informed consent
- Active bleeding requiring transfusion
- No arterial catheter in situ
- Proven other cause of low platelet count (e.g. heparin induced thrombocytopenia)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8904 |
| Other | METC AMC : METC 2020_089 |