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CompletedNCT03687541HEMO-CIHUpdated Dec 19, 2018

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

An observational study in In-hospital Falls, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-19.

Sponsored by Rennes University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
157
Ages
18 Years and older
Sex
All
01

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.

Read the detailed description

Retrospective, descriptive and non-interventional study over a period of 12 months (from 01/01/2017 to 31/12/2017), from unwanted events database of Rennes University Hospital.

Patients meeting criterias receive an information mail. Without opposition over a period of 3 weeks, datas will be treated, focusing on the event and its consequencies until hospital outing.

Baseline characteristics :

  • Demographic datas : age, sex
  • Antithrombotic treatement, treatment class and molecule
  • Last INR dosage before the fall for patients of vitamin K antagonists
  • Antithrombotic treatment indication : supra-ventricular arythmia, heart valve mecanical prothesis, severe left ventricle hypokinesia, venous thromboembolism, anti-phospholipid syndrome, myeloproliferative disorder, atheroma (in primary or secondary prevention)
  • Comorbidities : history of bleeding (including hemorrhagic stroke), haemostasis disorder, thrombocytopenia, anemia, chronic kidney disease, chronic liver disease, alcohol abuse, ischemic stroke or transient ischemic stroke, cognitive disoreder, active neoplasm, HAS-BLED score, HEMORRHAGE score
  • Other undergoing treatments : total number of medications, antihypertensive treatment, psychotropic treatment, non-steroid anti-inflamatory treatment

Description of fall-related bleeding events rate (until hospital outing) according to the severity :

  • Any severity bleedings
  • Major bleedings (hemorrhagic shock, deglobulisation, red blood cells transfusion required, vital or functional-threatening bleeding spot, uncontrolled hemorrhage requiring specialized haemostatic intervention)
  • Intracranial bleeding
  • Fatal bleeding

Modification of the antithrombotic prescription in the aftermath of the fall :

  • Discontinuation or suspension of antithrombotic treatment

Sub-group analysis for each previous item, according to undergoing antithrombotic treatment at the moment of the fall :

  • Curative-dose anticoagulant in monotherapy
  • Preventive-dose anticoagulant in monotherapy
  • Antiplatelet in monotherapy
  • Curative-dose anticoagulant and antiplatelet in association
  • Preventive-dose anticoagulant and antiplatelet in association
  • No antithrombotic treatement
02

Conditions studied

  • In-hospital Falls

Keywords

  • In-hospital falls
  • fall-related bleeding
  • anticoagulant-related bleeding
  • antiplatelet-related bleeding
  • antithrombotic-related bleeding
03

In context

Lead sponsor

Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Hospitalized patients in internal medicine unit for whom an in-hospital fall was reported

Inclusion criteria

  • Hospitalized patients in internal medicine unit in Rennes University Hospital, from 1/01/2017 to 31/12/2017
  • Age over 18
  • In-hospital fall reported in unwanted event database
  • Separated inclusion for each fall in the same patient

Exclusion criteria

Exclusion Criteria:

  • Adults on legal protection (safeguarding justice, trusteeship, guardianship) or deprived of liberty
  • Patient opposed to inculsion
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
157 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Any-severity fall-related hemorrhagic events rate

    All reported hemorrhagic events after a fall

    Time frame: The inclusion day

07

Study locations

1 site
  • Centre Hospitalier Universitaire de Rennes
    Rennes, 35, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03687541
Lead sponsor
Rennes University Hospital
Responsible party
Sponsor
First posted
Sep 27, 2018
Start date
Sep 7, 2018
Primary completion
Oct 10, 2018
Completion
Oct 10, 2018
Last update
Dec 19, 2018

Study contacts

Patrick Jego, MD PhD
principal investigator · Rennes University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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