The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With Rotational Thromboelastometry (ROTEM)

Hypoth.Acidosis.Rivarox.ROTEM

Rivaroxaban, a non-vitamin K oral anticoagulants, is increasingly used to prevent stroke in patients with atrium fibrillation. It has previously been demonstrated that a point-of-care coagulation instrument (ROTEM) can detect the effects of rivaroxaban. Further, the ROTEM instrument can also detect the effects of hypothermia and acidosis. Given that trauma induced coagulopathy is enhanced by both hypothermia, acidosis and rivaroxaban, the investigators want to investigate any synergistic effects between hypothermia or acidosis and rivaroxaban. In an attempt to do so the investigators designed the current experimental study with the purpose to investigate the effects of rivaroxaban together with hypothermia or acidosis using the ROTEM assay EXTEM. The hypothesis is that a synergistic prolongation of hypothermia or acidosis and rivaroxaban can be detected in the initiation of clot formation demonstrated in the primary outcome variable, clotting time of the ROTEM assay EXTEM. Secondary outcome variables include direct effect on clotting time and direct and synergistic effects on clot formation time and alfa angle of hypothermia and acidosis detected in the ROTEM assay EXTEM.

2022-09-04

2022-11-10

2022-11-10

Completed

15

Inclusion Criteria: * Adult patients ≥ 18 years old * any indication for starting treatment with rivaroxaban Exclusion Criteria: * recent medication, within the last month, with anticoagulating medication including Vitamin K antagonists and non-vitamin K antagonists, platelet inhibitors (not acetylsalicylic acid), non-steroidal anti-inflammatory drugs * previously diagnosed coagulopathy

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 15, 'type': 'ACTUAL'}}

2023-03-01