MedDataX Logo

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

NCT ID: NCT01056978

Last Updated: 2013-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemorrhage

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

palliative care unit bleeding thromboembolic hemorrhagic risk antithrombotic prophylaxis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patients

Patients admitted in a palliative care unit

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bernard TARDY, PHD

Role: STUDY_DIRECTOR

CIC-EC (CIE3)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Gérontologique Saint-Thomas

Aix-en-Provence, , France

Site Status

Hôpital Jean Minjoz - CHU de Besançon

Besançon, , France

Site Status

Hôpital Nord - CHU Clermont-Ferrand

Cébazat, , France

Site Status

CH de Chambéry

Chambéry, , France

Site Status

CH de Gap

Gap, , France

Site Status

La Maison de Gardanne

Gardanne, , France

Site Status

CHU Grenoble

Grenoble, , France

Site Status

CH Saint-Philibert

Lomme, , France

Site Status

CH Luynes - CHU Tours

Luynes, , France

Site Status

Hôpital Saint-Eloi - CHU de Montpellier

Montpellier, , France

Site Status

CHU Nantes

Nantes, , France

Site Status

CHU Nice

Nice, , France

Site Status

Maison Médicale Jeanne Garnier

Paris, , France

Site Status

Hôpital Sainte Perrine - APHP

Paris, , France

Site Status

GH Diaconnesses Croix Saint-Marie

Paris, , France

Site Status

CHU Lyon Sud

Pierre-Bénite, , France

Site Status

CH Puteaux

Puteaux, , France

Site Status

CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Hôpital Joseph Ducuing - CH Saint-Gaudens

Toulouse, , France

Site Status

Hôpital Paul Brousse APHP

Villejuif, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009-A01234-53

Identifier Type: OTHER

Identifier Source: secondary_id

0908039

Identifier Type: -

Identifier Source: org_study_id