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

Hemorrhage Clinical Trial

— RHESO  

Official title:

Predictive Factors for Major Bleeding Risk in Patients Admitted in a Palliativecare Unit - Etude RHESO - Etude Monocentrique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056978
• Other study ID #: 0908039
• Secondary ID: 2009-A01234-53
• Status: Completed
• Phase: N/A
• First received: January 26, 2010
• Last updated: August 6, 2013
• Start date: April 2010
• Est. completion date: December 2012

Study information

• Verified date: August 2013
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1230
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemorrhage

Locations

Country	Name	City	State
France	Centre Gérontologique Saint-Thomas	Aix en Provence
France	Hôpital Jean Minjoz - CHU de Besançon	Besançon
France	Hôpital Nord - CHU Clermont-Ferrand	Cébazat
France	CH de Chambéry	Chambery
France	CH de Gap	GAP
France	La Maison de Gardanne	Gardanne
France	CHU Grenoble	Grenoble
France	CH Saint-Philibert	Lomme
France	CH Luynes - CHU Tours	Luynes
France	Hôpital Saint-Eloi - CHU de Montpellier	Montpellier
France	CHU Nantes	Nantes
France	CHU Nice	Nice
France	GH Diaconnesses Croix Saint-Marie	Paris
France	Hôpital Sainte Perrine - APHP	Paris
France	Maison Médicale Jeanne Garnier	Paris
France	CHU Lyon Sud	Pierre Bénite
France	CH Puteaux	Puteaux
France	CHU de Saint-Etienne	Saint-Etienne
France	Hôpital Joseph Ducuing - CH Saint-Gaudens	Toulouse
France	Hôpital Paul Brousse APHP	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the symptomatic occurrence of major and clinical relevant bleeding during the three months study period.		3 month	No
Secondary	Predictive factors for major bleeding		3 month	No
Secondary	Incidence of venous thomboembolic symptomatic disease		3 month	No