Rivaroxaban versus low-molecular weight heparin prior to scheduled Ultrasound evaluatioN in patients with suspected Deep Vein Thrombosis

Recruiting

• Conditions: Deep vein thrombosis

• Registration Number: NL-OMON24892
• Lead Sponsor: Zuyderland MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 1000

Inclusion Criteria

We will include patients > 18 years in whom acute DVT of the lower extremity is suspected by their general practitioner based on either a high Wells score or positive D-dimer testing who were referred to Zuyderland MC for further evaluation and whom received pre-emptive anticoagulation (DOAC or LMWH) from their general practitioner.

Exclusion Criteria

-Patients suspected for symptomatic pulmonary embolism or DVT of the upper extremity (in these patients urgent evaluation is indicated, which should not be deferred to the next day).
-Patients not receiving pre-emptive anticoagulation either due to violation of the clinical protocol or because of a contra-indication according to the currently used clinical protocol, for example because of:
-Current use of anticoagulant drugs (DOACs, LMWHs, or vitamin-K antagonists). The use of antiplatelet drugs (aspirin, clopidogrel etc.) is allowed.
-Patients with a very high bleeding risk (as judged by the general practitioner or internist) which is considered to be a contra-indication for pre-emptive use of anticoagulation. For example in case of active major bleeding (e.g. 2 units of more blood or blood products transfused in 24 hours), recent clinically significant bleeding (within the last 7 days); thrombocytopenia (platelets less than 20 x 10^9/L), surgical procedure with high bleeding risk within in the last two weeks (e.g. head and neck surgery, neurosurgery or eye surgery), uncontrolled systolic hypertension (230/120 mmHg or higher). Exclusion is always allowed if bleeding risk is considered to be unacceptably high for other, unmentioned reasons.
-Pregnancy or breast feeding.
-Clinically significant liver disease (acute hepatitis, cirrhosis etc.).
-Concomitant use of strong cytochrome P-450 3A4 inhibitors (e.g., human immunodeficiency virus protease inhibitors or systemic ketoconazole) or inducers (e.g., rifampicin, carbamazepine, or phenytoin).
-Hypersensitivity to the active substance or to any of the excipients

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary study outcomes will be patients’ and physicians satisfaction, including patient reported outcome measures (PROMs) and patient reported experience measures (PREMs).