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

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ClinicalTrials.gov Identifier: NCT01056978
Recruitment Status : Completed
First Posted : January 27, 2010
Last Update Posted : August 7, 2013
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
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.

Condition or disease
Hemorrhage

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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 : April 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Group/Cohort
patients
Patients admitted in a palliative care unit



Primary Outcome Measures :
  1. The primary outcome is the symptomatic occurrence of major and clinical relevant bleeding during the three months study period. [ Time Frame: 3 month ]

Secondary Outcome Measures :
  1. Predictive factors for major bleeding [ Time Frame: 3 month ]
  2. Incidence of venous thomboembolic symptomatic disease [ Time Frame: 3 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056978


Locations
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Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Investigators
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Study Director: Bernard TARDY, PHD CIC-EC (CIE3)
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01056978    
Other Study ID Numbers: 0908039
2009-A01234-53 ( Other Identifier: AFSSAPS )
First Posted: January 27, 2010    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: August 2013
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
palliative care unit
bleeding
thromboembolic
hemorrhagic risk
antithrombotic prophylaxis
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes