D-Dimer For Vte
Posted Date: Apr 28, 2025
- Investigator: Gregory Fermann
- Specialties:
- Type of Study: Observational/Survey
The objectives of this study are to validate investigational -D-dimer system(s) used to measure human -D-dimer in citrated plasma collected from non-high pre test probablility patients suspected of having a VTE. The investigational -D-dimer sensitivity and Negative Predictive Value (NPV) for acute lower extremity DVT, acute PE and combined VTE will be assessed. Specificity, or relative VTE exclusion rate, will also be determined, with a target specificity of ~35%.The data from this study may be used in support of US and international regulatory submission to obtain an exclusionary claim for VTE as an intended use of the product. Data generated from this study may be subject to audit by regulatory agencies.
Criteria:
The Key Inclusion Criteria Are As Follows: Adult Outpatients Who Presented To An Emergency Room Or Clinic With Suspicion Of Acute Vte • Adult Outpatients Referred For Objective Testing Using Diagnostic Algorithms To Rule Out Acute Lower Extremity Dvt And/Or Acute Pe • Subject Provides Written Informed Consent To Participate In This Study • Subject Agrees To A 3-Month Follow-Up Interview If Required.
Keywords:
Thomboembolism, Blood Clot
For More Information:
Megan Slovenski
513 558 5281
slovenmc@ucmail.uc.edu