Deep vein thrombosis
Conditions
Interventions
Questionnaires
Sponsors
Zuyderland MC
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study outcomes will be patients’ and physicians satisfaction, including patient reported outcome measures (PROMs) and patient reported experience measures (PREMs). | — |
Secondary
| Measure | Time frame |
|---|---|
| A subgroup-analysis will be performed in patients with active malignancy. Moreover, cost-effectiveness analyses will be done on the difference between the use of dalteparin and rivaroxaban (including drug and pharmacy costs as well as time needed for a health care provider to initiate treatment). In additional analyses, data on number of patients, time to treatment, and duration of stay in the outpatient clinic will be compared to other hospitals in the region to estimate the impact on peak load in emergency departments and waiting times. Safety outcomes will be clinically relevant bleeding within 72 hours after administration of anticoagulant drug. Definitions are derived from the EINSTEIN study (N Engl J Med 2010;363:2499-2510): Major bleeding is defined as a clinically overt bleeding that is associated with a fall in the haemoglobin level of 20 g per liter (1.24 mmol/L) or more, or if it led to transfusion of two or more units of red cells, or if it was retroperitoneal, intracranial, occurred in a critical site, or contributed to death. Clinically relevant non-major bleeding is defined as overt spontaneous bleeding not meeting the criteria for major bleeding but associated with medical intervention, unscheduled contact with a physician, or associated with impairment of activities of daily life. Examples of these bleedings are spontaneous epistaxis or gingival bleeding lasting more than 5 minutes, macroscopic haematuria, macroscopic gastro-intestinal haemorrhage or haemoptysis (more than a few spots), intramuscular hematoma, or subcutaneous hematoma larger than 25 cm2. In addition, we will also register the occurrence of symptomatic pulmonary embolism within 72 hours after administration of anticoagulant drug, requiring evaluation by a physician or hospital admission. | — |
Contacts
Public ContactDaan van Twist
Zuyderland Medisch Centrum
Outcome results
None listed