In-hospital Falls Clinical Trial
Official title:
In-hospital Falls and Hemorrhagic Complications : a Descriptive Analysis in Rennes University Hospital
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.
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
;