NCT01056978

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Typical duration for all trials

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

August 7, 2013

Status Verified

August 1, 2013

Enrollment Period

2.7 years

First QC Date

January 26, 2010

Last Update Submit

August 6, 2013

Conditions

Hemorrhage

Keywords

palliative care unitbleedingthromboembolichemorrhagic riskantithrombotic prophylaxis

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is the symptomatic occurrence of major and clinical relevant bleeding during the three months study period.

    3 month

Secondary Outcomes (2)

  • Predictive factors for major bleeding

    3 month

  • Incidence of venous thomboembolic symptomatic disease

    3 month

Study Arms (1)

patients

Patients admitted in a palliative care unit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • years
  • admitted in a palliative care unit for a cancer, a pulmonary, a cardiac or a neurologic advanced disease

You may not qualify if:

  • life prognosis less than 48 hours
  • patients treated with curative doses of antithrombotic therapy
  • patients with follow up of 3 months is not possible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Centre Gérontologique Saint-Thomas

Aix-en-Provence, 13100, France

Location

Hôpital Jean Minjoz - CHU de Besançon

Besançon, 25000, France

Location

Hôpital Nord - CHU Clermont-Ferrand

Cébazat, 63118, France

Location

CH de Chambéry

Chambéry, 73011, France

Location

CH de Gap

Gap, 05000, France

Location

La Maison de Gardanne

Gardanne, 13120, France

Location

CHU Grenoble

Grenoble, 38043, France

Location

CH Saint-Philibert

Lomme, 59462, France

Location

CH Luynes - CHU Tours

Luynes, 37230, France

Location

Hôpital Saint-Eloi - CHU de Montpellier

Montpellier, 34295, France

Location

CHU Nantes

Nantes, 44000, France

Location

CHU Nice

Nice, 06200, France

Location

Maison Médicale Jeanne Garnier

Paris, 75015, France

Location

Hôpital Sainte Perrine - APHP

Paris, 75016, France

Location

GH Diaconnesses Croix Saint-Marie

Paris, 75571, France

Location

CHU Lyon Sud

Pierre-Bénite, 69495, France

Location

CH Puteaux

Puteaux, 92800, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42100, France

Location

Hôpital Joseph Ducuing - CH Saint-Gaudens

Toulouse, 31076, France

Location

Hôpital Paul Brousse APHP

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bernard TARDY, PHD

    CIC-EC (CIE3)

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2010

First Posted

January 27, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

August 7, 2013

Record last verified: 2013-08

Locations

FR(20)