Clinical trial NCT01056978: Predictive Factors for Major Bleeding Risk in Patients Admitted in a Palliative Care Unit
Official title: Predictive Factors for Major Bleeding Risk in Patients Admitted in a Palliativecare Unit - Etude RHESO - Etude Monocentrique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Keywords: palliative care unit
bleeding
thromboembolic
hemorrhagic risk
antithrombotic prophylaxis
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2010-01-27
Enrollment: 1230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

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.


Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome is the symptomatic occurrence of major and clinical relevant bleeding during the three months study period.
timeFrame: 3 month
Secondary outcomes:
measure: Predictive factors for major bleeding
timeFrame: 3 month
measure: Incidence of venous thomboembolic symptomatic disease
timeFrame: 3 month
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: Centre Gérontologique Saint-Thomas
city: Besançon
country: France
facility: Hôpital Jean Minjoz - CHU de Besançon
city: Chambery
country: France
facility: CH de Chambéry
city: Cébazat
country: France
facility: Hôpital Nord - CHU Clermont-Ferrand
city: GAP
country: France
facility: CH de Gap
city: Gardanne
country: France
facility: La Maison de Gardanne
city: Grenoble
country: France
facility: CHU Grenoble
city: Lomme
country: France
facility: CH Saint-Philibert
city: Luynes
country: France
facility: CH Luynes - CHU Tours
city: Montpellier
country: France
facility: Hôpital Saint-Eloi - CHU de Montpellier
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: CHU Nice
city: Paris
country: France
facility: Maison Médicale Jeanne Garnier
city: Paris
country: France
facility: Hôpital Sainte Perrine - APHP
city: Paris
country: France
facility: GH Diaconnesses Croix Saint-Marie
city: Pierre Bénite
country: France
facility: CHU Lyon Sud
city: Puteaux
country: France
facility: CH Puteaux
city: Saint-Etienne
country: France
facility: CHU de Saint-Etienne
city: Toulouse
country: France
facility: Hôpital Joseph Ducuing - CH Saint-Gaudens
city: Villejuif
country: France
facility: Hôpital Paul Brousse APHP
Study officials:
affiliation: CIC-EC (CIE3)
name: Bernard TARDY, PHD
role: STUDY_DIRECTOR
References: