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

NCT05669313 | Completed

• 1 other identifier: Hypoth.Acidosis.Rivarox.ROTEM
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Trauma; Hypothermia; Acidosis; Bleeding

Outcome Measures

Primary Outcomes (1)

• Clotting time of the ROTEM assay EXTEM

  Measured in seconds

  From inclusion to the day after inclusion when the second blood sample was taken

Secondary Outcomes (2)

• Clot formation time of the ROTEM assay EXTEM

  From inclusion to the day after inclusion when the second blood sample was taken

• Alpha Angle of the ROTEM assay EXTEM

  From inclusion to the day after inclusion when the second blood sample was taken

Study Arms (1)

Adult patients planned for treatment with rivaroxaban

Drug: Rivaroxaban 15 MG

Interventions

Rivaroxaban 15 MG DRUG

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

Adult patients planned for treatment with rivaroxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending the emergency department at Skåne University Hospital in Lund, Sweden

You may qualify if:

• Adult patients ≥ 18 years old
• any indication for starting treatment with rivaroxaban

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Kander: lead

Study Sites (1)

Skåne University Hospital

Lund, Skåne County, 22185, Sweden

Location

Related Publications (1)

• Sunnersjo L, Ymen I, Schott U, Hillarp A, Unden J, Kander T. Synergistic effects of rivaroxaban and hypothermia or acidosis on coagulation initiation measured with ROTEM(R): a prospective observational study. Thromb J. 2024 Oct 18;22(1):91. doi: 10.1186/s12959-024-00661-0.

  PMID: 39425155 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Hypothermia; Acidosis; Hemorrhage

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: December 30, 2022
• Study Start: September 4, 2022
• Primary Completion: November 10, 2022
• Study Completion: November 10, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)