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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01056978
First received: January 26, 2010
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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
Hemorrhage

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • The primary outcome is the symptomatic occurrence of major and clinical relevant bleeding during the three months study period. [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Predictive factors for major bleeding [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Incidence of venous thomboembolic symptomatic disease [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Enrollment: 1230
Study Start Date: April 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients
Patients admitted in a palliative care unit

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

community sample

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056978

Locations
France
Centre Gérontologique Saint-Thomas
Aix en Provence, France, 13100
Hôpital Jean Minjoz - CHU de Besançon
Besançon, France, 25000
CH de Chambéry
Chambery, France, 73011
Hôpital Nord - CHU Clermont-Ferrand
Cébazat, France, 63118
CH de Gap
GAP, France, 05000
La Maison de Gardanne
Gardanne, France, 13120
CHU Grenoble
Grenoble, France, 38043
CH Saint-Philibert
Lomme, France, 59462
CH Luynes - CHU Tours
Luynes, France, 37230
Hôpital Saint-Eloi - CHU de Montpellier
Montpellier, France, 34295
CHU Nantes
Nantes, France, 44000
CHU Nice
Nice, France, 06200
Hôpital Sainte Perrine - APHP
Paris, France, 75016
GH Diaconnesses Croix Saint-Marie
Paris, France, 75571
Maison Médicale Jeanne Garnier
Paris, France, 75015
CHU Lyon Sud
Pierre Bénite, France, 69495
CH Puteaux
Puteaux, France, 92800
CHU de Saint-Etienne
Saint-Etienne, France, 42100
Hôpital Joseph Ducuing - CH Saint-Gaudens
Toulouse, France, 31076
Hôpital Paul Brousse APHP
Villejuif, France, 94800
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Investigators
Study Director: Bernard TARDY, PHD CIC-EC (CIE3)
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01056978     History of Changes
Other Study ID Numbers: 0908039, 2009-A01234-53
Study First Received: January 26, 2010
Last Updated: August 6, 2013
Health Authority: France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
palliative care unit
bleeding
thromboembolic
hemorrhagic risk
antithrombotic prophylaxis

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2014