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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Completed

CT.gov ID

NCT01056978

Collaborator

Ministry of Health, France (Other)

1,230

Enrollment

Locations

Duration (Months)

61.5

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhage

Study Design

Study Type:

Observational

Actual Enrollment :

1230 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
patients Patients admitted in a palliative care unit

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Predictive factors for major bleeding [3 month]
Incidence of venous thomboembolic symptomatic disease [3 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre Gérontologique Saint-Thomas	Aix en Provence	France	13100
2	Hôpital Jean Minjoz - CHU de Besançon	Besançon	France	25000
3	CH de Chambéry	Chambery	France	73011
4	Hôpital Nord - CHU Clermont-Ferrand	Cébazat	France	63118
5	CH de Gap	GAP	France	05000
6	La Maison de Gardanne	Gardanne	France	13120
7	CHU Grenoble	Grenoble	France	38043
8	CH Saint-Philibert	Lomme	France	59462
9	CH Luynes - CHU Tours	Luynes	France	37230
10	Hôpital Saint-Eloi - CHU de Montpellier	Montpellier	France	34295
11	CHU Nantes	Nantes	France	44000
12	CHU Nice	Nice	France	06200
13	Maison Médicale Jeanne Garnier	Paris	France	75015
14	Hôpital Sainte Perrine - APHP	Paris	France	75016
15	GH Diaconnesses Croix Saint-Marie	Paris	France	75571
16	CHU Lyon Sud	Pierre Bénite	France	69495
17	CH Puteaux	Puteaux	France	92800
18	CHU de Saint-Etienne	Saint-Etienne	France	42100
19	Hôpital Joseph Ducuing - CH Saint-Gaudens	Toulouse	France	31076
20	Hôpital Paul Brousse APHP	Villejuif	France	94800