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HemorrhageRHESONCT01056978

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

An observational study of Hemorrhage, run by Centre Hospitalier Universitaire de Saint Etienne at 20 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hemorrhage
How many people
1,230 participants
Where
20 sitesFrance
Study dates
Apr 2010to Dec 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: community sample

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

France20 sites

  • Centre Gérontologique Saint-Thomas

    Aix-en-Provence, 13100

  • Hôpital Jean Minjoz - CHU de Besançon

    Besançon, 25000

  • Hôpital Nord - CHU Clermont-Ferrand

    Cébazat, 63118

  • CH de Chambéry

    Chambéry, 73011

  • CH de Gap

    Gap, 05000

  • La Maison de Gardanne

    Gardanne, 13120

  • CHU Grenoble

    Grenoble, 38043

  • CH Saint-Philibert

    Lomme, 59462

  • CH Luynes - CHU Tours

    Luynes, 37230

  • Hôpital Saint-Eloi - CHU de Montpellier

    Montpellier, 34295

  • CHU Nantes

    Nantes, 44000

  • CHU Nice

    Nice, 06200

  • Maison Médicale Jeanne Garnier

    Paris, 75015

  • Hôpital Sainte Perrine - APHP

    Paris, 75016

  • GH Diaconnesses Croix Saint-Marie

    Paris, 75571

  • CHU Lyon Sud

    Pierre-Bénite, 69495

  • CH Puteaux

    Puteaux, 92800

  • CHU de Saint-Etienne

    Saint-Etienne, 42100

  • Hôpital Joseph Ducuing - CH Saint-Gaudens

    Toulouse, 31076

  • Hôpital Paul Brousse APHP

    Villejuif, 94800

Other trials in France

About this study

Official title: 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.

Conditions
Hemorrhage
Keywords
palliative care unit, bleeding, thromboembolic, hemorrhagic risk, antithrombotic prophylaxis
Medical subject headings
Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01056978
Study groupRoleWhat they receive
patientsPatients admitted in a palliative care unit

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 month

Secondary outcomes (2)

  1. Predictive factors for major bleeding

    Measured: 3 month

  2. Incidence of venous thomboembolic symptomatic disease

    Measured: 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01056978
Sponsor's protocol ID
0908039
Other IDs
2009-A01234-53
Acronym
RHESO
Status last verified
Aug 2013
First submitted
26 Jan 2010
Last updated
7 Aug 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Hemorrhage, run by Centre Hospitalier Universitaire de Saint Etienne at 20 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01056978.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.

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