Duration of Therapeutic Anticoagulation in Patients With Pulmonary Embolism

NCT06912009 | Recruiting

• 1 other identifier: 9373
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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. 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). UFH treatment is reserved for patients at risk of hemodynamic instability, renal failure with a GFR \< 30 ml/min, or obesity. 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. It is generally accepted that this anticoagulation should be initiated at a curative dose as early as possible, as this reduces in-hospital mortality and 30-day mortality. 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 or have based their anticoagulation monitoring on aPTT and not on antiXa activity. 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.

Conditions

Pulmonary Embolism

Keywords

Pulmonary Embolism; Curative Anticoagulation; Fibrinolytic therapy; Thrombectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  Mean time to achieve effective anticoagulation, defined as the mean time between the initiation of curative anticoagulation and the first antiXa activity value greater than 0.3 units/ml in the case of antiXa monitoring, or an aPTT ratio \> 2 in the case of aPTT monitoring. In the case of monitoring by both aPTT ratio and antiXa activity, the antiXa activity value will be preferred.

  Up to 10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Réanimation Médicale - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Vincent CASTELAIN, MD, PhD

CONTACT

33.3.88.12.79.15; vincent.castelain@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 4, 2025
• Study Start: November 6, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-03

Locations

FR (1)