Clinical trial NCT06912009: Evaluation of the Duration of Obtaining Curative Anticoagulation in Patients With Clinically Significant Pulmonary Embolism in an Intensive Care Unit
Official title: Evaluation of the Duration of Obtaining Curative Anticoagulation in Patients With Clinically Significant Pulmonary Embolism in an Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Embolism
Keywords: Pulmonary Embolism
Curative Anticoagulation
Fibrinolytic therapy
Thrombectomy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient (≥18 years old) hospitalized in the intensive care unit of Hautepierre Hospital (Strasbourg University Hospitals UF 6250) between January 1, 2014, and December 31, 2023

Brief summary: Current management of intermediate- and high-risk pulmonary embolism is primarily based on curative subcutaneous or intravenous anticoagulation, with or without systemic fibrinolytic therapy or thrombectomy (8). Initial treatment with low-molecular-weight heparin (LMWH) or fondaparinux is preferred over unfractionated heparin (UFH) due to their lower risk of serious bleeding and heparin-induced thrombocytopenia (HIT) (9). UFH treatment is reserved for patients at risk of hemodynamic instability, renal failure with a GFR \< 30 ml/min, or obesity (8). Biological monitoring of anticoagulation efficacy can be performed by measuring the activated partial thromboplastin time (aPTT), as recommended by the European Society of Cardiology (ESC), or by measuring the antiXa activity of heparin, which has been shown to be beneficial in numerous studies (10,11,12). It is generally accepted that this anticoagulation should be initiated at a curative dose as early as possible (8), as this reduces in-hospital mortality and 30-day mortality (13). However, few studies have examined the impact of the time to achieve effective anticoagulation, and those that have done so have only done so in patients with high-risk pulmonary embolism (14) or have based their anticoagulation monitoring on aPTT and not on antiXa activity (13).

The proposed study aims to evaluate the time to obtain effective anticoagulation and its impact on mortality, thromboembolic recurrence and the occurrence of serious bleeding in patients with clinically significant pulmonary embolism, hospitalized in an intensive care unit as well as the factors that may influence this time. It will also allow to compare the practices of the studied center in terms of initial anticoagulation dose delivered, the initiation or not of a bolus and methods of monitoring anticoagulation with the literature in order to allow an improvement in patient care.


Eligibility criteria: Inclusion Criteria:

* Adult patient (≥18 years old)
* Hospitalized in the intensive care unit of Hautepierre Hospital (Strasbourg University Hospitals UF 6250) between January 1, 2014, and December 31, 2023
* With a diagnosis of pulmonary embolism confirmed by a thoracic CT angiogram, a thoracoabdominopelvic CT scan, or a lung scan
* Having received anticoagulation with curative-dose unfractionated heparin

Exclusion Criteria:

* Subjects who have expressed objection to the reuse of their data for scientific research purposes. - Patients diagnosed with pulmonary embolism prior to admission to the intensive care unit and for whom we cannot precisely determine the start date of anticoagulation (precision estimated to the nearest hour).
* Pulmonary embolism not confirmed by contrast imaging (CT angiography)
* Patients who have not received curative anticoagulation (contraindication)
* Patients already receiving curative anticoagulation with UFH at the time of diagnosis
* Patients with low-risk pulmonary embolism defined by an sPESI score of 0
* Subject under court protection, guardianship, or curatorship

Primary outcomes:
measure: To determine the time to effective anticoagulation with HNF in the treatment of high-risk and intermediate-risk pulmonary embolism in an intensive care unit.
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Réanimation Médicale - CHU de Strasbourg - France
Study officials:
References: