Predictive Factors for Major Bleeding Risk in Patients Admitted in a Palliative Care Unit (RHESO)
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| ClinicalTrials.gov Identifier: NCT01056978 |
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Recruitment Status
:
Completed
First Posted
: January 27, 2010
Last Update Posted
: August 7, 2013
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Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
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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 |
| 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 |
| Group/Cohort |
|---|
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patients
Patients admitted in a palliative care unit
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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 ]
Secondary Outcome Measures
:
- Predictive factors for major bleeding [ Time Frame: 3 month ]
- Incidence of venous thomboembolic symptomatic disease [ Time Frame: 3 month ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
| 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 | |
| Maison Médicale Jeanne Garnier | |
| Paris, France, 75015 | |
| Hôpital Sainte Perrine - APHP | |
| Paris, France, 75016 | |
| GH Diaconnesses Croix Saint-Marie | |
| Paris, France, 75571 | |
| 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) |
| Responsible Party: | Centre Hospitalier Universitaire de Saint Etienne |
| ClinicalTrials.gov Identifier: | NCT01056978 History of Changes |
| 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:
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palliative care unit bleeding thromboembolic hemorrhagic risk antithrombotic prophylaxis |
Additional relevant MeSH terms:
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Hemorrhage Pathologic Processes |