STA®-Liatest®D-Di-Exclusion of Venous Thromboembolism (DiET)
The purpose of this study is to demonstrate the ability of STA® Liatest® D-Di combined with a clinical pretest probability (PTP) to safely exclude pulmonary embolism (PE) or Deep Venous Thrombosis (DVT) in a 3 month follow-up.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||STA®-Liatest®D-Di-Exclusion of Venous Thromboembolism|
- To demonstrate the ability of STA Liatest DDi combined with a clinical pretest probability (PTP) to safely exclude pulmonary embolism or deep venous thrombosis in a 3 month follow-up [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]Occurence of pulmonary embolism or deep venous thrombosis during the 3 month follow-up after negative diagnosis (i.e. patients with PTP low/moderate and negative STA Liatest D-Di test)
- 1. To analyse results homogeneity (inter-centers) in the group "positive D-dimer result and negative diagnosis" (descriptive statistics only). 2. To determine prevalence of VTE in PTP high patients based on imaging results [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]1. Prevalence of VTE in PTP high patients based on imaging results.
Biospecimen Retention: Samples Without DNA
plasma samples (at least 1 aliquot 0.5 ml) will be collected at the initial visit of patients with low or moderate PTP
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
The study population will be selected from prospective, consecutive ambulatory outpatients suspected of having venous thromboembolism.
These patients will first be evaluated using the Wells score:
- patients with low or moderate pretest probability will be considered for D-dimer testing, those with D-dimer positive will be considered for an imaging procedure,
- patients with high pretest probability will be considered for an imaging procedure.
Patients with "low or moderate" pretest probability and a negative D-Dimer result will be followed for 3 months to evaluate potential development of deep venous thrombosis and/or pulmonary embolism.
These patients will be contacted by phone 3 month after their first visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221805
|Contact: Gilles PERNOD, MD PHD||+33476765717||GPernod@chu-grenoble.fr|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States|
|Principal Investigator: KABRHEL Christopher, MD|
|United States, North Carolina|
|Moses Cone Memorial Hospital||Recruiting|
|Greensboro, North Carolina, United States|
|Principal Investigator: Jay GROCE|
|United States, Ohio|
|Univeristy Medical Center||Completed|
|Colombus, Ohio, United States|
|United States, Pennsylvania|
|Lehigh Valley Hospital Health Network||Recruiting|
|Allentown, Pennsylvania, United States|
|Principal Investigator: RICHARDSON David, MD|
|United States, South Carolina|
|Medical Center of South Carolina||Completed|
|Charleston, South Carolina, United States|
|Maisonneuve Rosemont Hospital||Completed|
|Grenoble, France, 38043|
|IRCCS H San Raffaele||Completed|
|Principal Investigator:||GILLES PERNOD, MD PhD||University Hospital, Grenoble|