Accidental FallsFUKNONCT02244983
Falls Of Unknown Origin (FUKNO) - Are Morbidity and Mortality Predictable in Patients Presenting With Falls?
An observational study of Accidental Falls and Underlying Disease of Falls, run by University Hospital, Basel, Switzerland at 4 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Accidental Falls, Underlying Disease of Falls
- What is being tested?
- Patients History
- How many people
- 587 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 12 Nov 2014to 2 Dec 2021
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All fall patients aged 65 years and older who presented to the emergency department giving written informed consentent
Who may be able to join
- All fall patients aged 65 years and older who presented to the emergency department giving written informed consent
Who cannot join
- Patients below 65 years
- Non-fall patients above 65 years
- or lack of informed consent by patients or proxies
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Switzerland3 sites
University Hospital Basel
Basel, Canton of Basel-City, 4031
Cantonal Hospital Baselland, Bruderholz
Basel, 4101
Cantonal Hospital Baselland, Liestal
Liestal, 4410
About this study
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
- Prevalence of underlying disease
- Developing algorithms for initial assessment Disposition
- Establishing biomarker enhanced disposition planning by using risk-stratification tools b. Comparing geriatric emergency assessment to standardized disposition planning
- Conditions
- Accidental Falls, Underlying Disease of Falls
- Being tested
- Patients History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients HistoryOther
History taking and drawing of a blood sample
| Study group | Role | What they receive |
|---|---|---|
| EFAB 65 | Patients presenting to the emergency department with falls, above 65 years of age. Patients History will be taken as well as a blood sample Receives: Other: Patients History |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Data Collection via Case Report Form
Measured: 30 Days
Secondary outcomes (6)
Acute Morbidity
Data Collection via Case Report Form
Measured: 30 Days
Institutionalisation
Data Collection via interview with general practitioner
Measured: 180 Days
Disposition
Data collection via case report form
Measured: 30 Days
Mortality
Data Collection via Case Report Form
Measured: 90 Days
Mortality
Data Collection via Case Report Form
Measured: 180 Days
Mortality
Data Collection via Case Report Form
Measured: 365 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study start12 Nov 2014
- Primary completion30 Aug 2019
- Study completion2 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 587 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland Bingisser, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244983
- Sponsor's protocol ID
- FUKNO_Protokoll_17-07-14
- Acronym
- FUKNO
- Status last verified
- Jul 2022
- First submitted
- 18 Aug 2014
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Terhalle L, Arntz L, Hoffmann F, Arnold I, Hafner L, Picking-Pitasch L, Zuppinger J, Delport Lehnen K, Leuppi J, Somasundaram R, Nickel CH, Bingisser R. Nonspecific stress biomarkers for mortality prediction in older emergency department patients presenting with falls: a prospective multicenter observational study. Intern Emerg Med. 2025 Mar;20(2):585-595. doi: 10.1007/s11739-024-03693-6. Epub 2024 Jul 3.
PubMed 38960969
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Falls Of Unknown Origin (FUKNO) - Are Morbidity and Mortality Predictable in Patients Presenting With Falls?
- ClinicalTrials.gov ID
- NCT02244983
- Acronym / sponsor ID
- FUKNO / FUKNO_Protokoll_17-07-14
- Conditions
- Accidental Falls, Underlying Disease of Falls
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 587 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 12 Nov 2014 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Prevalence of underlying disease
- Developing algorithms for initial assessment Disposition
- Establishing biomarker enhanced disposition planning by using risk-stratification tools b. Comparing geriatric emergency assessment to standardized disposition planning
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EFAB 65 | – | Other: Patients HistoryPatients presenting to the emergency department with falls, above 65 years of age. Patients History will be taken as well as a blood sample |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All fall patients aged 65 years and older who presented to the emergency department giving written informed consentent
Key inclusion criteria (1 listed)
- All fall patients aged 65 years and older who presented to the emergency department giving written informed consent
Key exclusion criteria (3 listed)
- Patients below 65 years
- Non-fall patients above 65 years
- or lack of informed consent by patients or proxies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients HistoryHistory taking and drawing of a blood sample | Other | EFAB 65 |
Primary outcome
Mortality
Time frame: 30 Days
Data Collection via Case Report Form
6 secondary outcomes
Acute Morbidity
Time frame: 30 Days
Institutionalisation
Time frame: 180 Days
Disposition
Time frame: 30 Days
Mortality
Time frame: 90 Days
Mortality
Time frame: 180 Days
Mortality
Time frame: 365 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Derived from this study: PubMed 38960969Terhalle L, Arntz L, Hoffmann F, Arnold I, Hafner L, Picking-Pitasch L, Zuppinger J, Delport Lehnen K, Leuppi J, Somasundaram R, Nickel CH, Bingisser R. Nonspecific stress biomarkers for mortality prediction in older emergency department patients presenting with falls: a prospective multicenter observational study. Intern Emerg Med. 2025 Mar;20(2):585-595. doi: 10.1007/s11739-024-03693-6. Epub 2024 Jul 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland Bingisser, MD principal investigator
University Hospital, Basel, Switzerland
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Accidental Falls and Underlying Disease of Falls, run by University Hospital, Basel, Switzerland at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02244983, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.