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In-hospital Falls and Hemorrhagic Complications : a Descriptive Analysis in Rennes University Hospital

NCT03687541 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 157

Last updated 2018-12-19

No results posted yet for this study

Summary

Anticoagulant and antiplatelet treatments have well defined indactions, with a clearly proved benefit, respectivly for prevention of arterial and venous emblism and for prevention of athermo-related arterial thrombosis.

Bleeding risk represents the main adverse effect of these antithrombotic medications. Then benefit-risk ratio is sometimes difficult to evaluate, especially for elderly patients prone to fall (incidence of falls estimated to 30% per year for patients over 65), exposed on the one hand to thromboembolic risk and on the other hand to bleeding risk.

Associations between falls and antithrombotic-related bleeding risk had already been evaluated in several studies :

* Concerning anticoagulant treatments in patients at high risk of falls, retrospective studies shown a overrated risk of intracranial hemorrhage and mortality, but those results remain discordant wtih 3 major prospective studies on larger populations.
* Concerning antiplatelet treatments in patients at high risk of falls, majority of retrospective studies reported an overrated risk of major bleeding, intracranial bleeding and mortality, but datas remain fewer than for anticoagulant and results are as well discordant with prospective studies.
* No difference of morbi-mortality is clearly estalblished depending of antithrombotic treatment class (anticoagulant versus antiplatelet), however there is a cumulative risk in case of association of both anticoagulant and antiplatelet.
* Main factors associated with fall-related bleeding for patients on anticoagulant include age, female sex, anemia, chronic kidney disease, dementia and polymedication.

Thus, the purpose of this study is to specify whether occurrence of falls justify to reconsider prescription of antithrombotic treatments in patients having an indication of antiplatelet or anticoagulant therapy.

Conditions

  • In-hospital Falls

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Patrick Jego, MD PhD · Rennes University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-07
Primary Completion
2018-10-10
Completion
2018-10-10

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03687541 on ClinicalTrials.gov