Urine test for anticoagulants in stroke patients
Evaluation of a Urin-based Point-of-Care Testing Device for Direct Oral Anticoagulants in Patients With Acute Ischemic or Hemorrhagic Stroke
This study is testing a new urine test to quickly find out if stroke patients are taking blood-thinning medications, which could help doctors make better treatment decisions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Giessen Academic / other |
| Drugs / interventions | Idarucizumab |
| Locations | 1 site (Gießen, Hesse) |
| Trial ID | NCT06037200 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate a urine-based point-of-care testing device designed to detect direct oral anticoagulants (DOACs) in patients diagnosed with stroke. It seeks to determine whether this test can quickly identify patients on DOACs and if it offers time advantages over traditional blood-based coagulation assessments. The feasibility of using this device in acute stroke care settings will also be assessed. By improving the identification of anticoagulant use, the study hopes to enhance treatment decisions for stroke patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a clinical diagnosis of ischemic or hemorrhagic stroke who are being treated at the University Hospital Giessen.
Not a fit: Patients with contraindications for intravenous thrombolysis or those requiring immediate endovascular thrombectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this test could lead to faster and more accurate treatment decisions for stroke patients on anticoagulants.
How similar studies have performed: While the approach of urine-based testing for anticoagulants is relatively novel, similar studies have shown promise in improving patient management in acute care settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Gießen, Hesse
- Department of Neurology, University Hospital Giessen — Gießen, Hesse, Germany (Recruiting)
Study contacts
- Principal investigator: Stefan Gerner, MD — Department of Neurology, University Hospital Giessen/Germany
- Study coordinator: Stefan Gerner, MD
- Email: stefan.gerner@neuro.med.uni-giessen.de
- Phone: +49-641/985-45301
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.