The SYMPTOMS - SYstematic Elderly Medical Patients Thromboprophylaxis: Efficacy on Symptomatic OutcoMeS - Study
NCT ID: NCT02379806
Last Updated: 2022-07-05
Study Results
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Basic Information
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COMPLETED
PHASE3
2560 participants
INTERVENTIONAL
2015-09-03
2020-12-29
Brief Summary
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The landmark MEDENOX trial and others demonstrated the efficacy of low molecular weight heparins (LMWH) in reducing a composite outcome of symptomatic and asymptomatic events, the latter accounting for the vast majority of events.
Publication of these trials led to the implementation of thromboprophylaxis policies in hospitals, which acceptance has been variable. More recently, the use of thromboprophylaxis has been challenged after the publication of 1) a negative trial that used 'death from any cause' as main outcome, 2) a systematic review showing the lack of a clear efficacy on the risk of pulmonary embolism or death, 3) negative trials using new oral anticoagulants, 4) the last version of the American College of Chest Physicians Guidelines, focusing on symptomatic events only, downgraded its recommendation for thromboprophylaxis in medical patients to a 1B recommendation, restricting its use to patients 'at increased risk of thrombosis' and recommending against the use of thromboprophylaxis in patients at low risk of thrombosis, patients bleeding or at high risk of bleeding.
However, a limitation of this interpretation of the data is that in most trials, patients with screened asymptomatic events were treated with anticoagulants, preventing the occurrence of symptomatic events during follow-up. Moreover, subgroup analyses showed that elderly patients were at high risk of thrombosis in these trials, and that LMWH could be particularly efficient in this subgroup of patients. Conversely, their risk of bleeding is also higher than in younger patients and the current trials were not powered to detect a difference in the bleeding risk between groups. Finally, the diagnostic and therapeutic management of VTE is more challenging in the elderly. Therefore, we planned a randomized controlled trial on the efficacy of LMWH for the prevention of symptomatic VTE in elderly patients.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Active enoxaparin 40 mg
One 0.4 ml prefilled syringe containing 40 mg enoxaparin active substance administered once daily for 10 ± 4 days
Enoxaparin
Placebo of enoxaparin 40 mg
One 0.4 ml placebo syringe of enoxaparin 40 mg administered once daily for 10 ± 4 days
Placebo
Interventions
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Enoxaparin
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Admitted to hospital for an acute medical illness
* Anticipated duration of hospitalization of at least 4 days
* Life expectancy of at least 3 months
Exclusion Criteria
* Planned medical procedure.
* Routine health assessment requiring admission for baseline/trending of health status (e.g., routine colonoscopy).
* Admission encountered for another life circumstance that causes no bearing on health status and requires no medical intervention (e.g., lack of housing, economic inadequacy, care-giver respite, family circumstances, administrative).
* Hypersensitivity to heparin
* History of Heparin Induced Thrombocytopenia
* Active bleeding
* Bacterial endocarditis
* Platelet count of less than 80,000 per cubic millimeter
* Patients who require anticoagulant therapy for any indication, and those who received any type of anticoagulant therapy for \> 48 hours
* Organic lesion prone to bleeding.
* Hemorrhagic events or bleeding tendency due to hemostasis disorders.
* Concomitant use of aspirin (\> 160 mg/day), clopidogrel (\> 75 mg/day), or of combined antiplatelet therapy
* Creatinine clearance \< 15 ml/min
* Unable or unwilling to consent
* Ischemic stroke + hemorrhagic transformation
* Patient requiring admission to Intensive Care Unit
70 Years
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Locations
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Centre Hospitalier d'Agen
Agen, , France
CHU Angers
Angers, , France
CH Angoulême
Angoulême, , France
CH d'Arras
Arras, , France
CH Béthune
Béthune, , France
Hôpital Jean Verdier (APHP)
Bondy, , France
CHU Bordeaux
Bordeaux, , France
HIA Clermont-Tonnerre
Brest, , France
CHRU Brest
Brest, , France
CH Public du Cotentin
Cherbourg, , France
CH Louis Mourier de Colombes
Colombes, , France
CHU de Dijon
Dijon, , France
CHU Grenoble
Grenoble, , France
CHD Vendée
La Roche-sur-Yon, , France
Groupe Hospitalier Le Havre
Le Havre, , France
CHU Rouen
Le Petit-Quevilly, , France
CHRU de Lille
Lille, , France
CHU Limoges
Limoges, , France
CHD Vendée - Site de Luçon
Luçon, , France
Hôpital Edouard Herriot - CHU Lyon
Lyon, , France
CHU Lyon
Lyon, , France
Hôpital de la Timone - AP-HM
Marseille, , France
Clinique Mutualiste Médico-chirurgical "Beau Soleil"
Montpellier, , France
CH des Pays de Morlaix
Morlaix, , France
CHU Nancy
Nancy, , France
CHU de Nantes
Nantes, , France
Hôpital Cimiez - CHU Nice
Nice, , France
HEGP - Paris
Paris, , France
Hôpital Lariboisiere
Paris, , France
Hôpital Saint-Antoine (APHP)
Paris, , France
Hôpital Broca- APHP
Paris, , France
Hôpita Cochin - APHP
Paris, , France
Institut Mutualiste Montsouris
Paris, , France
CH Périgueux
Périgueux, , France
CHU Poitiers
Poitiers, , France
CH de Cornouaille - Quimper
Quimper, , France
CHU Rennes
Rennes, , France
Hôpital Charles Nicolle- CHU Rouen
Rouen, , France
CHU La Réunion - Site Félix Guyon
Saint-Denis, , France
CHU de Saint Etienne
Saint-Etienne, , France
CHU La Réunion - site du GHSR
Saint-Pierre, , France
CHRU Strasbourg- Service HTA et Maladies Vasculaires
Strasbourg, , France
CHU Strasbourg - Service de Médecine Interne
Strasbourg, , France
CH Intercommunal Toulon La Seyne sur Mer
Toulon, , France
HIA Sainte-Anne Toulon
Toulon, , France
Hôpitaux Universitaires de Genève
Geneva, , Switzerland
Countries
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References
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Mottier D, Girard P, Couturaud F, Lacut K, Le Moigne E, Paleiron N, Guellec D, Sanchez O, Cogulet V, Laporte S, Marhic G, Mismetti P, Presles E, Robert-Ebadi H, Mahe I, Plaisance L, Reny JL, Darbellay Farhoumand P, Cuvelier C, Le Henaff C, Lambert Y, Danguy des Deserts M, Rousseau Legrand C, Boutreux S, Bleher Y, Decours R, Trinh-Duc A, Armengol G, Benhamou Y, Daumas A, Guyot SL, De Carvalho H, Lamia B, Righini M, Meyer G, Le Gal G. Enoxaparin versus Placebo to Prevent Symptomatic Venous Thromboembolism in Hospitalized Older Adult Medical Patients. NEJM Evid. 2023 Aug;2(8):EVIDoa2200332. doi: 10.1056/EVIDoa2200332. Epub 2023 Jun 27.
Other Identifiers
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2014-000311-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
29BRC14.0012 SYMPTOMS
Identifier Type: -
Identifier Source: org_study_id
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