Clinical trial · Interventional
Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy
Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy : HYDRA Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is 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 computed tomography pulmonary angiography (CTPA) alone in a randomized study.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cardiovascular Diseases | — | UNRESOLVED | — |
| Diagnosis | — | UNRESOLVED | — |
| Embolism | — | UNRESOLVED | — |
| Embolism and Thrombosis | — | UNRESOLVED | — |
| Lung Diseases | — | UNRESOLVED | — |
| Pulmonary Embolism | — | UNRESOLVED | — |
| Respiratory Tract Diseases | — | UNRESOLVED | — |
| Vascular Diseases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CTPA | Procedure | — | UNRESOLVED |
| YEARS algorithm | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- YEARS algorithm
- description
- Patients randomized to this arm will be evaluated according to the YEARS algorithm.
- interventionNames
- Procedure: YEARS algorithm
- type
- ACTIVE_COMPARATOR
- label
- CTPA as single test
- description
- Patients randomized to this arm will undergo a contrast enhanced CTPA.
- interventionNames
- Procedure: CTPA
Primary outcomes (3)
- measure
- Recurrent PE
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 randomization, including recurrent or local metastatic malignancy * Outpatients and hospitalized patients * Age ≥ 18 years * Signed and dated informed consent, available for start of the trial procedure Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * 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 * contrast allergy Hemodynamic instability at presentation (as a consequence of concurrent acute PE or otherwise), indicated by at least one of the following: * systolic blood pressure (SBP) \< 100 mm Hg, or heart rate \>120 beats per minute or SBP drop by \> 40 mm Hg, for \> 15 min * need for catecholamines to maintain adequate organ perfusion and a systolic blood pressure of \> 100 mmHg * Need for cardiopulmonary resuscitation * Inability to follow-up * Life expectancy less than 3 months
References
Publications (1)
- DERIVEDMartens ESL, Akerboom B, Baumgartner C, Brouwer RE, Cavallaro C, Coppens M, Costantino G, Couturaud F, D'Errico A, van Dooren YPA, Gianni F, van der Griend R, Grootenboers MJJH, Hugli O, van der Hulle T, Jaderi Z, Jimenez D, Kamphuisen PW, Lanting VR, Leentjens J, Maas ML, Mahe I, van Meer OA, van Mens TE, Out M, Pola R, Pulver D, Raskin J, Righini M, Sprenger RA, Stals MAM, Talerico R, Tritschler T, Ten Wolde M, Klok FA, Huisman MV; HYDRA study group. Electronic address: research_interne@lumc.nl. A study protocol for a randomised controlled trial evaluating the safety and efficiency of the YEARS algorithm versus computed tomography pulmonary angiography only for suspected acute pulmonary embolism in patients with cancer: the Hydra Study. Thromb Res. 2026 Jul;263:109745. doi: 10.1016/j.thromres.2026.109745. Epub 2026 Jun 11. PMID 42365759