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

Predictive Factors for Major Bleeding Risk in Patients Admitted in a Palliativecare Unit - Etude RHESO - Etude Monocentrique

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01056978

Acronym

RHESO

Enrollment

1230

Registered

2010-01-27

Start date

2010-04-30

Completion date

2012-12-31

Last updated

2013-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhage

Keywords

palliative care unit, bleeding, thromboembolic, hemorrhagic risk, antithrombotic prophylaxis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The primary outcome is the symptomatic occurrence of major and clinical relevant bleeding during the three months study period.	3 month

Secondary

Measure	Time frame
Predictive factors for major bleeding	3 month
Incidence of venous thomboembolic symptomatic disease	3 month

Countries

France

Outcome results