Predictive Factors for Major Bleeding Risk in Patients Admitted in a Palliative Care Unit

Completed

• Conditions: Hemorrhage

• Registration Number: NCT01056978
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Even if most patients in palliative care units presented with well-recognized risks factors of venous thromboembolism (VTE) (eg: active cancer, bed rest, previous history of venous thrombosis), the incidence of VTE in palliative setting is unknown. By consequence, the efficacy and safety of antithrombotic prophylaxis in such a population is not established. Indeed, patients admitted in palliative care units were not included in trials evaluating the potential effect of antithrombotic drugs in regard to their poor prognosis at short term. In addition, the main role of prophylaxis is to prevent sudden death from pulmonary emboli and is thus a life prolonging therapy which is viewed as counterintuitive to palliative care philosophy and inappropriate on grounds of futility. Nevertheless, the current use of Low Molecular Weight Heparin in palliative care units seems to increase particularly in patients with advanced malignancy. The identification of high hemorrhagic risks in palliative care patients could help the decision of antithrombotic prophylaxis initiation. For this, the investigators conducted a multicenter prospective longitudinal study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-26
• Study First Submitted QC: 2010-01-26
• Study First Posted: 2010-01-27
• Study Start: 2010-04
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1230

Inclusion Criteria

• 18 years
• admitted in a palliative care unit for a cancer, a pulmonary, a cardiac or a neurologic advanced disease

Exclusion Criteria

• life prognosis less than 48 hours
• patients treated with curative doses of antithrombotic therapy
• patients with follow up of 3 months is not possible

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the symptomatic occurrence of major and clinical relevant bleeding during the three months study period.	3 month

Secondary Outcome Measures

Name	Time	Method
Predictive factors for major bleeding	3 month
Incidence of venous thomboembolic symptomatic disease	3 month

Trial Locations

Locations (20)

Centre Gérontologique Saint-Thomas; 🇫🇷 Aix en Provence, France

CHU Nantes; 🇫🇷 Nantes, France

Hôpital Jean Minjoz - CHU de Besançon; 🇫🇷 Besançon, France

Hôpital Sainte Perrine - APHP; 🇫🇷 Paris, France

Hôpital Nord - CHU Clermont-Ferrand; 🇫🇷 Cébazat, France

CH Luynes - CHU Tours; 🇫🇷 Luynes, France

GH Diaconnesses Croix Saint-Marie; 🇫🇷 Paris, France

CHU de Saint-Etienne; 🇫🇷 Saint-Etienne, France

CHU Lyon Sud; 🇫🇷 Pierre Bénite, France

CHU Grenoble; 🇫🇷 Grenoble, France

CH Puteaux; 🇫🇷 Puteaux, France

Hôpital Paul Brousse APHP; 🇫🇷 Villejuif, France

CH de Chambéry; 🇫🇷 Chambery, France

La Maison de Gardanne; 🇫🇷 Gardanne, France

CHU Nice; 🇫🇷 Nice, France

Hôpital Saint-Eloi - CHU de Montpellier; 🇫🇷 Montpellier, France

Maison Médicale Jeanne Garnier; 🇫🇷 Paris, France

Hôpital Joseph Ducuing - CH Saint-Gaudens; 🇫🇷 Toulouse, France

CH Saint-Philibert; 🇫🇷 Lomme, France

CH de Gap; 🇫🇷 GAP, France