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

January 26, 2010
August 6, 2013
April 2010
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01056978 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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Predictive Factors for Major Bleeding Risk in Patients Admitted in a Palliative Care Unit
Predictive Factors for Major Bleeding Risk in Patients Admitted in a Palliativecare Unit - Etude RHESO - Etude Monocentrique

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

community sample

Hemorrhage
Not Provided
patients
Patients admitted in a palliative care unit
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1230
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01056978
0908039, 2009-A01234-53
Yes
Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Study Director: Bernard TARDY, PHD CIC-EC (CIE3)
Centre Hospitalier Universitaire de Saint Etienne
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP