The SYMPTOMS (SYstematic elderly Medical Patients Thromboprophylaxis : efficacy on symptomatic OutcoMeS) study

Phase 1

• Conditions: Venous Thromboembolism; MedDRA version: 18.0Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxisSystem Organ Class: 100000004865; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2014-000311-13-FR
• Lead Sponsor: CHRU de Brest

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-22
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5030

Inclusion Criteria

•Patient aged 75 years or older
•Admitted to hospital for an acute medical illness
•Anticipated duration of hospitalization of at least 4 days
•Life expectancy of at least 3 months

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5030

Exclusion Criteria

•Admission for one of the following reasons:
oPlanned medical procedure.
oRoutine health assessment requiring admission for baseline/trending of health status (e.g., routine colonoscopy).
oAdmission 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 100,000 per cubic millimeter
•Patients who require anticoagulant therapy for any indication, and those who received any type of anticoagulant therapy for > 48 hours
•Active peptic ulcer
•Concomitant use of aspirin (> 160 mg/day), clopidogrel (> 75 mg/day), or of combined antiplatelet therapy
•Previous admission to hospital within the last month
•Creatinine clearance < 15 ml/min
•Unable or unwilling to consent
•Ischemic stroke + hemorrhagic transformation
•Patient requiring admission to Intensive Care Unit

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified