Validation of Falls Decision Rule to Exclude Intracranial Bleeding in Geriatric Fall Patients

NCT06525727 | Completed Results

• 1 other identifier: 12.01.2024.48
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intracranial Hemorrhages

Keywords

Falls Rule; geriatric; rule; external validation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With the Clinically Important Intracranial Bleeding

  The primary outcome is 'clinically significant intracranial hemorrhage' identified within 42 days following the initial presentation in the emergency department. 'Clinically significant intracranial hemorrhage' is defined as hemorrhage within the cranial vault, encompassing subdural, intracerebral, intraventricular, subarachnoid, epidural hemorrhage, and cerebral contusion, necessitating medical or surgical intervention. Medical intervention is defined as any of the following actions: temporary or permanent cessation of anticoagulant or antiplatelet medications; administration of an antifibrinolytic agent; reversal of anticoagulation; or hospitalization for neurological monitoring. These criteria align with those established in the original study.

  From baseline to 42 days (Patients will be followed up for 42 days after the fall and evaluated for delayed intracranial haemorrhage).

Secondary Outcomes (2)

• Number of Participant With Neurosurgical Intervention

  42 day

• Number of Patients With Mortality

  42 day

Study Arms (1)

Patients aged 65 years and over

Patients aged 65 years and over who came to the emergency department with a fall on level ground ((either inside or outside), off a chair, toilet seat or out of bed) within the last 48 hours

Other: Falls Decision Rule

Interventions

Falls Decision Rule OTHER

The Falls Decision Rule is a rule used to assess the risk of intracranial haemorrhage in geriatric patients and to prevent brain tomography (CT) in low-risk patients. This rule recommends that brain CT is not necessary in patients who do not have significant head trauma, memory loss, newly developing neurological examination disorder, or frailty score lower than 5 after a fall.

Patients aged 65 years and over

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of geriatric patients aged 65 years and older who present to the emergency department within 48 hours of experiencing a fall on level ground ((either inside or outside), off a chair, toilet seat, or out of bed). These patients will be included if they provide informed consent or if their legal guardians provide consent if the patients are unable to do so. The study aims to externally validate the Falls Decision Rule to exclude intracranial bleeding in this specific population. All patients meeting the inclusion criteria and none of the exclusion criteria will be enrolled in the study, and they will be observed for clinically significant intracranial bleeding for up to 42 days post-fall.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Pendik, Turkey (Türkiye)

Location

Related Publications (2)

• Gray I, de Wit K. Fast-tracking falls - expediting emergency care with evidence. CJEM. 2025 Aug;27(8):580-581. doi: 10.1007/s43678-025-00970-x. No abstract available.

  PMID: 40856903 RESULT

• Kudu E, Altun M, Danis F, Karacabey S, Sanri E, Denizbasi A. Validating the falls decision rule: optimizing head CT use in older adults with ground-level falls. CJEM. 2025 Aug;27(8):629-637. doi: 10.1007/s43678-025-00937-y. Epub 2025 May 13.

  PMID: 40360963 RESULT

MeSH Terms

Conditions

Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study has limitations, primarily its single-center design, which may limit generalizability. However, as an external validation study, the findings suggest applicability to broader populations. Variability in physician judgment on CT use is another limitation, despite standardized training. Not all patients underwent CT at the initial visit, posing a risk of missed CIIB. However, a 42-day follow-up ensured comprehensive assessment, with no patients lost to follow-up.

Results Point of Contact

• Title: Dr. Emre Kudu
• Organization: Marmara University School of Medicine

dr.emre.kudu@gmail.com

+902166254545

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: January 20, 2024
• Primary Completion: October 1, 2024
• Study Completion: November 12, 2024
• Last Updated: January 22, 2026
• Results First Posted: July 30, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)