Completed

NCT Number: NCT03687541

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.

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Key information

Conditions

In-hospital Falls

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Rennes

Rennes, 35, France

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

Any-severity fall-related hemorrhagic events rate

Time frame: The inclusion day

All reported hemorrhagic events after a fall

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: HEMO-CIH

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Sep 27, 2018
Registry last updated: Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.