Safety and efficiency of the YEARS algorithm versus computed tomography pulmonary angiography alone for suspected pulmonary embolism in patients with malignancy - The Hydra Study
- Conditions
- English keywords:- diagnosis- pulmonary embolism- malignancyDutch keywords:- diagnose- longembolie- maligniteit
- Registration Number
- NL-OMON20408
- Lead Sponsor
- eiden University Medical Center (LUMC)
- Brief Summary
none
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1566
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method