ROTEM in critically ill patients at risk for DIC

Rotational Thromboelastometry in critically ill patients at risk for disseminated intravascular coagulation

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON22092

Enrollment

200

Registered

2020-09-16

Start date

2020-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disseminated intravascular coagulation

Interventions

None listed

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactRomein Dujardin

Amsterdam University Medical Center, University of Amsterdam

r.w.dujardin@amsterdamumc.nl0205666328

Outcome results