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The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM

NCT05669313 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2023-03-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Rivaroxaban 15 MG

Rivaroxaban 15 mg after inclusion and on the morning after inclusion, i.e., before blood sampling

Sponsors & Collaborators

  • Thomas Kander

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-04
Primary Completion
2022-11-10
Completion
2022-11-10

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05669313 on ClinicalTrials.gov