To prospectively validate the safety and efficiency of management according to the YEARS algorithm to safely rule out clinically suspected PE in patients with active malignancy to be compared with `standard' management by CTPA alone in a…
ID
Source
Brief title
Condition
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety: Recurrent venous thromboembolism during three months follow-up in
patients with initially normal diagnostic tests.
Efficiency: Number of CTPA needed in each randomisation group.
Secondary outcome
To evaluate the occurrence (timing, location and severity) of recurrent
symptomatic VTE during follow-up in both study arms in order to better
differentiate between missed PE diagnoses and new onset VTE
To compare differences in the rate of isolated sub-segmental PE, defined as
CTPA demonstrating an intraluminal filling defect in a sub-segmental artery
with no filling defect visualized at more proximal artery levels, in both study
arms
To assess the occurrence of incidental VTE, defined as thromboembolism that was
detected by means of imaging tests performed for reasons other than clinical
suspicion of venous thromboembolism[18], during follow up in both study arms
To evaluate contrast material induced complications (allergic reactions and
contrast material induced nephropathy) in both study arms.
To evaluate usage and safety of antithrombotic treatment in both study groups
To evaluate practice patterns of anticoagulation therapy during end-of-life
care in terminally ill patients with cancer.
To evaluate quality of life in patients with PE at baseline or follow-up in
this study by implementing the Pulmonary Embolism Quality of Life (PEmb-QoL)
Questionnaire.
To post-hoc evaluate the performance of the 4-Level Pulmonary Embolism Clinical
Probability Score (4PEPS), in patients randomized for YEARS within the Hydra
study.
Background summary
Recently, the YEARS-algorithm was demonstrated to be a safe and efficient
diagnostic strategy for patients with clinically suspected pulmonary embolism
(PE). It is recognized that diagnostic algorithms for pulmonary embolism (PE)
may not be as effective and safe in patients with malignancy, due to the low
specificity of D-dimer test in that setting. A diagnostic algorithm that could
safely rule out PE in patients with malignancy without performing computed
tomography pulmonary angiography (CTPA) could nonetheless improve patient care.
Study objective
To prospectively validate the safety and efficiency of management according to
the YEARS algorithm to safely rule out clinically suspected PE in patients with
active malignancy to be compared with `standard' management by CTPA alone in a
randomized study.
Study design
The Hydra-study will be a randomized controlled, multicenter international
trial with a non-inferiority analysis for the main safety outcome (rate of
3-month VTE); if non-inferiority has been demonstrated at secondary stage a
superiority analysis for the efficiency judgment criterion (rate of unnecessary
CTPA) will be performed. Patients will be randomized between management
according to the YEARS algorithm versus CTPA alone.
Intervention
Patients will be randomized into management by either YEARS-algorithm or direct
CTPA, on a 1:1 basis and stratified by center.
The randomization process will occur directly after signing informed consent,
before a D-dimer test is ordered or at least before the result of an ordered
D-dimer test has become available.
Study burden and risks
Not applicable (both the YEARS algorithm as the CTPA scan are performed in
daily practice).
albinusdreef 2
Leiden 2333ZA
NL
albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
- Clinically suspected PE as judged by the treating clinician
- Any type of active malignancy (other than basal-cell or squamous-cell
carcinoma of the skin), defined as diagnosis within six months before the study
inclusion (as confirmed histologically or high suspicion as judged by the
clinician), receiving treatment for malignancy at time of inclusion or during 6
months prior to randomisation or in the presence of metastases, including
recurrent or local metastatic malignancy
- Age >= 18 years
- Signed and dated informed consent, available for start of the trial procedure
Exclusion criteria
- Symptoms for more than 10 days
- Medical or psychological condition that would not permit completion of the
study or signing of informed consent, including life expectancy less than 3
months, or unwillingness to sign informed consent
- Treatment with full-dose therapeutically dosed anticoagulation:
o if initiated 24 hours or more prior to eligibility assessment
(prophylactic dose with Low Molecular Weight Heparin (LMWH) or direct oral
anticoagulants (DOAC) is permitted), or;
o if initiation is expected prior to eligibility assessment for different
indication (i.e., atrial fibrillation)
- Contraindication to CTPA
o contrast allergy
o impaired kidney function (eGFR <30 ml/min/1,73m2)
o pregnancy
- Hemodynamic instability at presentation (as a consequence of concurrent acute
PE or otherwise), indicated by at least one of the following:
o systolic blood pressure (SBP) < 100 mm Hg, or heart rate >120 beats per
minute (unless arrhythmia) or SBP drop by > 40 mm Hg, for > 15 min
o need for catecholamines to maintain adequate organ perfusion and a systolic
blood pressure of > 100 mmHg
o need for cardiopulmonary resuscitation
- Suggestion of PE on previously performed oncologic CT scan, for which now
PE-specific diagnostic testing is only performed as means of verification
- Participating in another concurrent study on thromboprophylaxis
- Prior participation in the Hydra study
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL68754.058.19 |