Predictive Factors for Major Bleeding Risk in Patients Admitted in a Palliative Care Unit (RHESO)
This study is currently recruiting participants.
Verified July 2012 by Centre Hospitalier Universitaire de Saint Etienne
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
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: July 2, 2012
Last verified: July 2012
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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 ]
| Estimated Enrollment: | 1200 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056978
Contacts
| Contact: Bernard TARDY, MD-PHD | +33(0)477127788 | bernardtardy@yahoo.fr |
| Contact: Nacim CHENNIT, CRA | 033(0)477120826 | nacim.chennit@chu-st-etienne.fr |
Locations
| France | |
| Centre Gérontologique Saint-Thomas | Recruiting |
| Aix en Provence, France, 13100 | |
| Contact: Fréderic Ravallec | |
| Principal Investigator: Frederic Ravallec, MD | |
| Hôpital Jean Minjoz - CHU de Besançon | Recruiting |
| Besançon, France, 25000 | |
| Contact: Regis AUBRY, MD | |
| Principal Investigator: Régis AUBRY, MD | |
| CH de Chambéry | Recruiting |
| Chambery, France, 73011 | |
| Contact: Pierre BASSET, MD | |
| Principal Investigator: Pierre BASSET, MD | |
| Hôpital Nord - CHU Clermont-Ferrand | Recruiting |
| Cébazat, France, 63118 | |
| Contact: Raymond Hermet, MD | |
| Principal Investigator: Raymond Hermet, MD | |
| CH de Gap | Recruiting |
| GAP, France, 05000 | |
| Contact: Alain Derniaux, MD | |
| Principal Investigator: Alain DERNIAUX, MD | |
| La Maison de Gardanne | Recruiting |
| Gardanne, France, 13120 | |
| Contact: Jean-Marc La Piana, MD | |
| Principal Investigator: Jean-Marc La Piana, MD | |
| CHU Grenoble | Recruiting |
| Grenoble, France, 38043 | |
| Contact: Guillemette Laval, MD | |
| Principal Investigator: Guillemette Laval, MD | |
| CH Saint-Philibert | Recruiting |
| Lomme, France, 59462 | |
| Contact: Didier De Broucker, MD | |
| Principal Investigator: Didier De Broucker, MD | |
| CH Luynes - CHU Tours | Recruiting |
| Luynes, France, 37230 | |
| Contact: Donatien Mallet, MD | |
| Principal Investigator: Donatien Mallet, MD | |
| Hôpital Saint-Eloi - CHU de Montpellier | Recruiting |
| Montpellier, France, 34295 | |
| Contact: Josyane CHEVALLIER, MD | |
| Principal Investigator: Josyane CHEVALLIER, MD | |
| CHU Nantes | Recruiting |
| Nantes, France, 44000 | |
| Contact: Nathalie Denis, MD | |
| Principal Investigator: Nathalie DENIS, MD | |
| CHU Nice | Recruiting |
| Nice, France, 06200 | |
| Contact: Jean-François CIAIS, MD | |
| Principal Investigator: Jean-François CIAIS, MD | |
| Hôpital Sainte Perrine - APHP | Recruiting |
| Paris, France, 75016 | |
| Contact: Jean-Marie GOMAS, MD | |
| Principal Investigator: Jean-Marie Gomas, MD | |
| Sub-Investigator: Daniel TRIBOUT, MD | |
| GH Diaconnesses Croix Saint-Marie | Recruiting |
| Paris, France, 75571 | |
| Contact: Gilbert DESFOSSES, MD | |
| Principal Investigator: Gilbert DESFOSSES, MD | |
| Sub-Investigator: Stéphane PICARD, MD | |
| Maison Médicale Jeanne Garnier | Recruiting |
| Paris, France, 75015 | |
| Contact: Daniel D'Herouville, MD | |
| Principal Investigator: Daniel D'Herouville, MD | |
| Sub-Investigator: Frederic GUIRIMAND, MD | |
| CHU Lyon Sud | Recruiting |
| Pierre Bénite, France, 69495 | |
| Contact: Marilène Filbert, MD | |
| Principal Investigator: Marilène Filbert, MD | |
| CH Puteaux | Recruiting |
| Puteaux, France, 92800 | |
| Contact: Alexis BURNOD, MD | |
| Principal Investigator: Alexis BURNOD, MD | |
| Sub-Investigator: Bernard DEVALLOIS, MD | |
| CHU de Saint-Etienne | Recruiting |
| Saint-Etienne, France, 42100 | |
| Contact: Anne RICHARD, MD | |
| Principal Investigator: Anne RICHARD, MD | |
| Sub-Investigator: Thomas CELARIER, MD | |
| Sub-Investigator: Sophie BAYLE, MD | |
| Hôpital Joseph Ducuing - CH Saint-Gaudens | Recruiting |
| Toulouse, France, 31076 | |
| Contact: Thierry Marmet, MD | |
| Principal Investigator: Thierry Marmet, MD | |
| Hôpital Paul Brousse APHP | Recruiting |
| Villejuif, France, 94800 | |
| Contact: Sylvain Pourchet, MD | |
| Principal Investigator: Sylvain Pourchet, MD | |
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: | July 2, 2012 |
| 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 May 16, 2013