Status:

UNKNOWN

Urin-based Point-of-Care Testing for Direct Oral Anticoagulants in Stroke Patients

Lead Sponsor:

University of Giessen

Conditions:

Stroke

Eligibility:

All Genders

18+ years

Brief Summary

The goal of this study is to test a urine-based point-of-care testing device for direct oral anticoagulants in patients with stroke. The main questions are: * Can the test identify patients with dire...

Detailed Description

Stroke is the second leading cause of death worldwide and the most common cause of acquired disability in adulthood. During the acute phase of ischemic brain infarction, the goal of therapy is the rap...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Patient age ≥18 years at the time of admission
  • Clinical diagnosis of ischemic or hemorrhagic stroke.
  • Treatmet at our certified stroke-unit, University Hospital Giessen.
  • Phase 1 only: Confirmed intake of a direct oral anticoagulant (DOAC) for at least 48 hours (test group) or no intake of a DOAC (control group for specificity determination)
  • Phase II only, anamnestic intake of DOAC or no information about OAC-intake.
  • Phase II only, presentation with 4.5 hours after onset.
  • Exclusion Criteria (only Phase II):
  • Contraindications for intravenous thrombolysis other than intake of DOAC
  • large vessel occlusion with indication for immediate endovascular thrombectomy
  • chronic renal insufficiency with need for hemodialysis

Exclusion

    Key Trial Info

    Start Date :

    January 1 2023

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    July 31 2024

    Estimated Enrollment :

    200 Patients enrolled

    Trial Details

    Trial ID

    NCT06037200

    Start Date

    January 1 2023

    End Date

    July 31 2024

    Last Update

    September 14 2023

    Active Locations (1)

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    1

    Department of Neurology, University Hospital Giessen

    Giessen, Hesse, Germany, 35392