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OpenTrials
Completed

NCT Number: NCT02244983

Falls Of Unknown Origin (FUKNO) - Are Morbidity and Mortality Predictable in Patients Presenting With Falls?

It is the investigators goal to identify the prevalence of underlying diseases, make disposition more rational, and establish risk stratification tools in elderly patients presenting with falls. Additionally, the outcome of standard care (clinical assessment only for disposition) will be compared with a new approach combining the standard of care with biomarker assisted disposition of elderly patients presenting with falls. Therefore the investigators are looking at the following points.

Emergency department work-up

1. Prevalence of underlying disease 2. Developing algorithms for initial assessment Disposition

a. Establishing biomarker enhanced disposition planning by using risk-stratification tools b. Comparing geriatric emergency assessment to standardized disposition planning

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Key information

Conditions

Accidental Falls Underlying Disease of Falls

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité Campus Benjamin Franklin, Berlin, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All fall patients aged 65 years and older who presented to the emergency department giving written informed consent

Exclusion criteria

  • Patients below 65 years
  • Non-fall patients above 65 years
  • or lack of informed consent by patients or proxies

Treatment and study plan

Patients History

Other

History taking and drawing of a blood sample

Primary outcomes

  1. Mortality

    Time frame: 30 Days

    Data Collection via Case Report Form

Secondary outcomes

  1. Acute Morbidity

    Time frame: 30 Days

    Data Collection via Case Report Form

  2. Institutionalisation

    Time frame: 180 Days

    Data Collection via interview with general practitioner

  3. Disposition

    Time frame: 30 Days

    Data collection via case report form

  4. Mortality

    Time frame: 90 Days

    Data Collection via Case Report Form

  5. Mortality

    Time frame: 180 Days

    Data Collection via Case Report Form

  6. Mortality

    Time frame: 365 Days

    Data Collection via Case Report Form

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Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: FUKNO

Important dates

Study start
2014
Primary completion
2019
Study completion
2021
First posted
Sep 19, 2014
Registry last updated
Jul 21, 2022

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.

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