Testing blood clotting in stroke patients on blood thinners
Qualitative Coagulation Testing With the CoaguChek(R) Pro II Point-of-Care Test System and aPTT Test Cards in Patients Before and After First Intake of Direct Oral Anticoagulants
This study is testing a quick blood test to see if it can accurately measure blood thinner levels in stroke patients who can't share their medication history.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Tuebingen) |
| Trial ID | NCT04679298 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of CoaguChek point-of-care testing to measure the levels of direct oral anticoagulants (DOACs) in stroke patients. It aims to determine the correlation between the test results and the actual plasma levels of DOACs, which are crucial for making timely treatment decisions in emergency situations. The study focuses on patients who have recently started anticoagulation therapy and may not be able to communicate their medication history due to their condition. By providing rapid diagnostic information, the study seeks to improve patient outcomes in acute stroke scenarios.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are stroke patients recently started on DOAC therapy for secondary prevention.
Not a fit: Patients who have taken vitamin K antagonists or other anticoagulants shortly before the study or those with abnormal coagulation values will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to quickly assess anticoagulant levels in stroke patients, leading to more effective and timely treatment decisions.
How similar studies have performed: Previous studies have shown promising results with point-of-care testing for anticoagulants, but this specific approach with CoaguChek is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Stroke patients, who were newly started on oral anticoagulation with apixaban, edoxaban, dabigatran or rivaroxaban for secondary prevention of thromboembolic events * informed consent Exclusion Criteria: * Vitamin K antagonists ≤ 14 days prior to study participation * Prior DOAC intake ≤ 72 hours * Low-molecular weight heparin ≤ 24 hours * Unfractionated heparin ≤ 12 hours * Heparinoids (e.g. Fondaparinux) ≤ 72 hours * Abnormal coagulation values at baseline (Quick \< 70% or activated thromboplastin time (aPTT) \> 40sec.) * History of coagulopathy
Where this trial is running
Tuebingen
- University Hospital Tuebingen — Tuebingen, Germany (Recruiting)
Study contacts
- Study coordinator: Sven Poli, MD MSc
- Email: sven.poli@uni-tuebingen.de
- Phone: +49(0)707129
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.