Evaluation of a D-Dimer assay
Research type
Research Study
Full title
Sample Collection in support of Clinical Performance Evaluation of the Roche Tina-quant D-Dimer Gen. 2 assay for c4c family in the evaluation of patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) with or without Deep Vein Thrombosis with a low or intermediate pretest probability
IRAS ID
215088
Contact name
Michael Hoffmann
Contact email
Sponsor organisation
Roche Diagnostics GmbH
Duration of Study in the UK
0 years, 5 months, 16 days
Research summary
The study will be performed to demonstrate the clinical performance of the Roche D-Dimer test to rule out proximal deep vein thrombosis and/or pulmonary embolism in patients suspected of having either of these conditions with a low or intermediate pretest probability according to the Wells criteria applicable for the condition. The results of the study will be used to support the submission by demonstrating the rule out claim for venous thromboembolism for CE marking.
Consecutively enrolled subjects presenting in the Emergency Department with suspected pulmonary embolism and/or deep vein thrombosis and a low or intermediate pretest probability according to the Wells criteria for the respective condition will be enrolled in the study. Subcohorts for deep vein thrombosis and pulmonary embolism respectively will be enrolled. In order to determine the clinical truth, subjects with no confirmed diagnosis of pulmonary embolism or deep vein thrombosis will be followed for 90 days after discharge from the Emergency Department. The subcohorts will be analyzed separately and in combination as a Venous thromboembolism cohort. The D-Dimer values of blood samples obtained from the study subjects will be measured post hoc and correlated to the clinical diagnosis of Pulmonary Embolism and/or deep vein thrombosis.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
17/EE/0047
Date of REC Opinion
20 Feb 2017
REC opinion
Further Information Favourable Opinion