N/A
N=800
Validation of Falls Decision Rule to Exclude Intracranial Bleeding in Geriatric Fall Patients
Intracranial Hemorrhages
Bottom Line
View on ClinicalTrials.gov: NCT06525727 ↗Enrolled (actual)
800
Serious AEs
—
Results posted
Jul 2025
Primary outcome: Primary: Number of Participants With the Clinically Important Intracranial Bleeding — 48; 1 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Falls Decision Rule (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Marmara University
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With the Clinically Important Intracranial Bleeding |
48; 1 | — |
| SECONDARY Number of Participant With Neurosurgical Intervention |
6; 0 | — |
| SECONDARY Number of Patients With Mortality |
12; 34 | — |
Summary
Although falls are the most important cause of intracranial hemorrhage in the population over 65, studies have shown that bleeding occurs in only 5% of geriatric patients who fall. Guidelines have been developed to assist the clinician in identifying patients at risk of intracranial hemorrhage due to the relatively low incidence but significant morbidity and mortality. The 'Falls Decision Rule' was developed by de Wit et al. in 2023 to assess the need for CT in this patient group. In this study, external validation of this newly developed score was planned to evaluate its safety, applicability, and authenticity.
Eligibility Criteria
Inclusion Criteria
- Patients aged 65 years and older.
- Patients who presented to the emergency department within 48 hours of a fall.
- Patients who provided informed consent to participate in the study or whose legal guardians provided consent if the patients are unable to do so.
Exclusion Criteria
- Patients who have already been included in the study previously.
- Patients who refuse medical treatment or withdraw consent during the study period.
- Patients with incomplete data necessary for the study.
Data sourced from ClinicalTrials.gov (NCT06525727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.