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.
ID
Bron
Verkorte titel
Aandoening
Disseminated intravascular coagulation
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Single blood draw between day 1 - 4 of ICU stay.
Publiek
Romein Dujardin
0205666328
r.w.dujardin@amsterdamumc.nl
Wetenschappelijk
Romein Dujardin
0205666328
r.w.dujardin@amsterdamumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- No informed consent
- Active bleeding requiring transfusion
- No arterial catheter in situ
- Proven other cause of low platelet count (e.g. heparin induced thrombocytopenia)
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL8904 |
Ander register | METC AMC : METC 2020_089 |