To assess the extent of pulmonary thrombo-embolic obstruction and cardiopulmonary function at presentation and after 6 months of anticoagulant treatment in patients with an acute pulmonary embolism. To assess risk factors for persistent obstruction…
ID
Source
Brief title
Condition
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pulmonary thrombo-embolic obstruction after 6 months of treatment,
cardiopulmonary function (incidence of chronic thrombo-embolic hypertension),
recurrent pulmonary embolism.
Secondary outcome
Not applicable
Background summary
In a systematic review, it was shows that more than 50% of all patients with a
pulmonary embolism have incomplete resolution of the embolism, 6 months after
diagnosis. The studies differed largely in patient selection, duration of
treatment, imaging test and timing of follow-up scan.
It is currently not very well known which patients will get recurrent pulmonary
embolism and chronic thrombo-embolic hypertension and the reason they develop
these complications
An increased D-dimer level after stopping anticoagulant treatment was
associated with increased risk of recurrence in patients with deep vein
thrombosis. It is unknown how D-dimer levels behave during treatment. ideally,
levels of blood coagulation activation, measured during treatment, could
simplify decisions for duration of treatment.
Study objective
To assess the extent of pulmonary thrombo-embolic obstruction and
cardiopulmonary function at presentation and after 6 months of anticoagulant
treatment in patients with an acute pulmonary embolism. To assess risk factors
for persistent obstruction and/or recurrent pulmonary embolism or deep vein
thrombosis. And assess the incidence of recurrent pulmonary embolism and
chronic thrombo-embolic hypertension.
Study design
A prospective multi-center cohort study.
Twelve hospitals are participating in this study.
Study burden and risks
A second CT-scan is performed after 6 months of anticoagulant treatment. The
effective radiation dose of a single CT scan varies between 2.8 and 3.9 mSV,
and this constitutes the amount of additional radiation as a consequence of
this study. Risk of this additional radiation depends on the age of the patient.
At the same as the CT-scan an appointment is made for blood sampling and two
questionnaires.
One month after the second scan, a visit is planned for control and blood
sampling.
After this a half yearly follow-up is planned, this will be done by an
interview by telephone about quality of life and cardio-pulmonary function.
Postbus 9600
2300 RC Leiden
NL
Postbus 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
Patients with a pulmonary embolism, diagnosed by helical computed tomography (CT)
Exclusion criteria
Age < 18 years
Pregnancy
Impossibility to return for follow-up
Inserted vena cava filter or thrombolytic therapy
Allergy to intravenous iodinated contrast
Renal insufficiency (estimated creatinine clearance < 30 ml/min)
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 |
---|---|
CCMO | NL21243.058.07 |