Hydra Study: YEARS Algorithm Compared to Direct Computed Tomography in Cancer Patients with Suspected Pulmonary Embolism

not available

ICTRP Trial ID
NL7752 (ICTRP)

Official title (approved by ethics committee)
Safety and efficiency of the YEARS algorithm versus computed tomography pulmonary angiography alone for suspected pulmonary embolism in patients with malignancy (BASEC)

Academic title
Safety and efficiency of the YEARS algorithm versus computed tomography pulmonary angiography alone for suspected pulmonary embolism in patients with malignancy (ICTRP)

Public title
Safety and efficiency of the YEARS algorithm versus computed tomography pulmonary angiography alone for suspected pulmonary embolism in patients with malignancy - The Hydra Study (ICTRP)

Disease under investigation
English keywords: - diagnosis - pulmonary embolism - malignancy Dutch keywords: - diagnose - longembolie - maligniteit
(ICTRP)

Intervention under investigation
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. The two randomized arms will exist of diagnostic management according to the YEARS algorithm and diagnostic management by CTPA alone.
(ICTRP)

Type of trial
Interventional (ICTRP)

Trial design
Randomized controlled trial, Open (masking not used), Active, Parallel (ICTRP)

Inclusion/Exclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following 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 (ICTRP)

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:
- 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 that was initiated 24 hours or more prior to eligibility assessment
- Contraindication to CTPA
o contrast allergy
o impaired kidney function (eGFR <30 ml/min/1,73m2)
- 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 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

Primary and secondary end points
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. Safety is defined as the number of recurrent venous thromboembolism during three months follow-up in patients with normal initial diagnostic tests. Efficacy is defined as the number of CT scans performed at baseline.
(ICTRP)

1. 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.
2. 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
3. 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
4. To evaluate contrast material induced complications (allergic reactions and contrast material induced nephropathy) in both study arms.
5. To evaluate usage and safety of antithrombotic treatment in both study groups
6. To evaluate practice patterns of anticoagulation therapy during end-of-life care in terminally ill patients with cancer.
7. To evaluate quality of life in patients with pulmonary embolism at baseline and follow-up as measured by the Pulmonary Embolism Quality of Life (PEmb-QoL) Questionnaire.
8. 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.
(ICTRP)

Registration date
14.05.2019 (ICTRP)

Incorporation of the first participant
23.07.2019 (ICTRP)

Secondary sponsors
not available

Additional contacts
Emily Martens, E.S.L.Martens@lumc.nl, +31-715298096, Leiden University Medical Center (ICTRP)

Secondary trial IDs
NL7752, METC LUMC : ABR research file number NL68754.058.19 (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://trialsearch.who.int/Trial2.aspx?TrialID=NL7752 (ICTRP)