ROTEM in critically ill patients at risk for DIC
Recruiting
- Conditions
- Disseminated intravascular coagulation
- Registration Number
- NL-OMON22092
- Lead Sponsor
- Amsterdam UMC, location AMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
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/
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)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Distinguish patients based upon ROTEM profiles that may benefit from timely anticoagulant strategies<br>Compare ROTEM profiles and other parameters of coagulation between patients who have DIC due to different clinical risk factors<br>Determine a critical fibrinogen to nucleosome ratio that corresponds to the development of DIC and thrombosis <br>Relate nucleosome levels to other markers of endothelial activation and coagulation<br>Determine specific clinical risk factors for bleeding and thrombosis in DIC