Prospective study comparing conventional coagulation diagnostics with viscoelastometry in patients requiring reversal of the effects of oral anticoagulants

Prospective study comparing conventional coagulation diagnostics with viscoelastometry in patients requiring reversal of the effects of oral anticoagulants - MEDOR

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00038023

Enrollment

100

Registered

2025-11-11

Start date

2025-04-01

Completion date

Unknown

Last updated

2025-11-24

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

Conditions

D68.35

Interventions

Group 1: Patients requiring reversal of the effects of oral anticoagulants Coagulation is measured using a conventional coagulation laboratory, a calibrated anti-Xa level, a ClotPro, a ROTEM and a GEM

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Certain or probable intake of a factor Xa antagonist within the last 24 hours - Referral to the 24/7 anticoagulation service by the doctor on duty, in accordance with internal SOPs

Exclusion criteria

Exclusion criteria: Patients with known hereditary coagulation disorders (von Willebrand syndrome, haemophilia A, B or C, factor VII deficiency, hereditary thrombocytopathies)

Design outcomes

Primary

Measure	Time frame
Correlation of the measured clotting time (CT) in ClotPro, ROTEM and GEM Hemochron with the calibrated anti-Xa measurement at 15 minutes, 2 hours, 6 hours and 24 hours after administration of andexanet alfa or PPSB.	—

Secondary

Measure	Time frame
- Comparison of baseline sample results: POC-VET vs. dXI plasma levels (local, through calibrated anti-Xa measurement) vs. dXI plasma levels (reference laboratory University Hospital Aachen, calibrated dXI ELISA) vs. thrombin function parameters. - Comparison of the results of samples after antagonisation: POC-VET vs. dXI plasma level (UKD, by calibrated anti-Xa measurement) vs. dXI plasma level (reference laboratory University Hospital Aachen, calibrated dXI ELISA) vs. parameters of thrombin function. - The time until receipt of the test result is determined as a surrogate for the time from arrival to antagonisation (door-to-reversal time) and compared between POC-VET and dXI plasma levels (UKD central laboratory). - Costs for POC VET and calibrated dXI plasma levels are determined as an average per patientand compared.	—

Measure

Time frame

- Comparison of baseline sample results: POC-VET vs. dXI plasma levels (local, through calibrated anti-Xa measurement) vs. dXI plasma levels (reference laboratory University Hospital Aachen, calibrated dXI ELISA) vs. thrombin function parameters. - Comparison of the results of samples after antagonisation: POC-VET vs. dXI plasma level (UKD, by calibrated anti-Xa measurement) vs. dXI plasma level (reference laboratory University Hospital Aachen, calibrated dXI ELISA) vs. parameters of thrombin function. - The time until receipt of the test result is determined as a surrogate for the time from arrival to antagonisation (door-to-reversal time) and compared between POC-VET and dXI plasma levels (UKD central laboratory). - Costs for POC VET and calibrated dXI plasma levels are determined as an average per patientand compared.

—

Countries

Germany

Contacts

Public ContactLars Heubner

Klinik und Poliklinik für Anästhesiologie, Universitätsklinikum Carl Gustav Carus an der TU Dresden

lars.heubner@ukdd.de+4935145811660

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026