No registrations found.
ID
Source
Brief title
Health condition
Deep venous thrombosis, diep veneuze trombose
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint, recurrent VTE, will be classified as certain or uncertain, based on the classification used in the Dutch MEGA study (Timp et al. J Thromb Haemost 2015)
Secondary outcome
* Cause of recurrent VTE: provoked or unprovoked (as defined earlier)
* All-cause mortality
* VTE-specific mortality: o VTE reported as cause of death in patient health care database (i.e. medical reports, autopsy reports or correspondence to primary health care physician)
Background summary
Unprovoked venous thrombo-embolism (VTE) has a two to three fold higher risk of recurrence after cessation of anticoagulation therapy, when compared to provoked VTE. Provoked VTE is treated for only three to six months after the elimination of the provoking factor. In unprovoked VTE this cannot be achieved. The initial anticoagulation therapy is therefore extended beyond the three to six months. However, anticoagulation therapy induces a clinically relevant bleeding risk. Therefore, effort should be made to identify patient categories with a lower risk of recurrence within the group of patients with a unprovoked VTE. From 2008 to 2010 the a cohort study, the BEAST, was performed in the University Medical Center Groningen, in which patients at the emergency department presenting with pulmonary embolism and/or thrombosis were asked whether they experienced transient inflammatory/infectious signs (e.g. the flu or a cold) before the onset of the thrombosis. It was shown that these transient inflammation/infection was associated with a higher risk of thrombosis. Currently transient inflammation/infection is not considered as a risk factor for thrombosis, thus thrombosis preceded by these complaints are treated as unprovoked VTE. In this study, we aim to determine and to compare the rate of recurrent VTE in patients with provoked and unprovoked index-VTE preceded and not preceded with transient inflammation/infection-associated index-VTE in the BEAST-cohort.
Study objective
We hypothesize that transient inflammation/infection-associated deep venous thrombosis has a similar recurrence risk as 'classic' provoked deep venous thrombosis.
Study design
Start of study
Intervention
none
Inclusion criteria
Patients with a first proximal DVT (located in the popliteal, femoral or iliacal veins) with or without PE or single PE included in the BEAST-study performed between 2008 and 2010 in the University Medical Center Groningen
Exclusion criteria
-
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5047 |
| NTR-old | NTR7445 |
| Other | UMCG Research Registry : 201800412 |