Falls Of Unknown Origin (FUKNO) - Are Morbidity and Morta... | NCT02244983

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

NCT02244983

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Jul 21, 2022Actual

Enrollment

587Actual

Phase

Not provided

Conditions

Accidental Falls
Underlying Disease of Falls

Interventions

Patients History

Countries

Germany
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 12, 2014Actual

Primary Completion Date

Aug 30, 2019Actual

Completion Date

Dec 2, 2021Actual

First Submitted Date

Aug 18, 2014

First Submission Date that Met QC Criteria

Sep 16, 2014

First Posted Date

Sep 19, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2022

Last Update Posted Date

Jul 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

30 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

587Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Other: Patients History

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patients History	Other	History taking and drawing of a blood sample	EFAB 65

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Data Collection via Case Report Form	30 Days

Secondary Outcomes

Measure	Description	Time Frame
Acute Morbidity	Data Collection via Case Report Form	30 Days
Institutionalisation	Data Collection via interview with general practitioner

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roland Bingisser, MD	University Hospital, Basel, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité Campus Benjamin Franklin, Berlin		Berlin		12203	Germany
University Hospital Basel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38960969	Derived	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.