Trial Outcomes & Findings for Validation of Falls Decision Rule to Exclude Intracranial Bleeding in Geriatric Fall Patients (NCT NCT06525727)

Last Updated: 2026-01-22

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

800 participants

Primary outcome timeframe

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

Results posted on

2026-01-22

Participant Flow

The study recruited patients aged 65 years and older who presented to the emergency department of Marmara University Pendik Training and Research Hospital within 48 hours of a fall on level ground, from a chair, toilet seat, or out of bed. Recruitment began on January 20, 2024, and continued until the required sample size was reached on October 1, 2024, ensuring adequate participant inclusion.

Participant milestones

Participant milestones
Measure	Patients Who Did Not Undergo Head CT Scan on Index Visit This group includes patients aged 65 years and older who presented to the emergency department following a ground-level fall but did not undergo head CT imaging during their initial visit. The decision not to perform a CT scan was made by the treating emergency physician based on clinical assessment and existing decision rules. These patients were monitored for delayed intracranial bleeding through a 42-day follow-up period.	Patients Who Underwent Head CT Scan on Index Visit This group includes patients aged 65 years and older who presented to the emergency department following a ground-level fall and underwent head CT imaging during their initial visit. The decision to perform a CT scan was made by the treating emergency physician based on clinical assessment and existing decision rules. These patients were evaluated for intracranial bleeding at the time of presentation and monitored for delayed bleeding through a 42-day follow-up period.
Overall Study STARTED	259	541
Overall Study COMPLETED	259	541
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Identified With CIIB on Initial Visit and 42 Day Follow-up n=49 Participants This group includes patients aged 65 years and older who were diagnosed with clinically important intracranial bleeding (CIIB) either at the initial emergency department visit or during the 42-day follow-up period. CIIB was defined as intracranial bleeding requiring medical or surgical intervention or resulting in mortality. Patients in this group were managed according to clinical guidelines, and those not initially identified with CIIB were closely monitored for delayed bleeding.	Patients Without CIIB n=751 Participants This group includes patients aged 65 years and older who were not diagnosed with clinically important intracranial bleeding (CIIB) during the initial emergency department visit or the 42-day follow-up period. These patients either did not undergo head CT or had a negative CT result at presentation, with no subsequent evidence of intracranial bleeding requiring medical or surgical intervention. Additionally, they exhibited no signs of bleeding throughout the follow-up period and did not experience fatal outcomes related to CIIB.	Total n=800 Participants Total of all reporting groups
Age, Continuous	80.0 years n=49 Participants	78.0 years n=751 Participants	78.0 years n=800 Participants
Sex: Female, Male Female	22 Participants n=49 Participants	457 Participants n=751 Participants	479 Participants n=800 Participants
Sex: Female, Male Male	27 Participants n=49 Participants	294 Participants n=751 Participants	321 Participants n=800 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Turkey	49 participants n=49 Participants	751 participants n=751 Participants	800 participants n=800 Participants
Confirmed history of head trauma	41 Participants n=49 Participants	407 Participants n=751 Participants	448 Participants n=800 Participants
Unclear history of head trauma	3 Participants n=49 Participants	36 Participants n=751 Participants	39 Participants n=800 Participants
Confirmed history of amnesia of events	20 Participants n=49 Participants	69 Participants n=751 Participants	89 Participants n=800 Participants
Unclear history of amnesia of events	12 Participants n=49 Participants	27 Participants n=751 Participants	39 Participants n=800 Participants
Clinical Frailty Scale score 1 Healthy, active and very fit	3 Participants n=49 Participants	85 Participants n=751 Participants	88 Participants n=800 Participants
Clinical Frailty Scale score 2 No disease symptoms, occasional exercise	9 Participants n=49 Participants	170 Participants n=751 Participants	179 Participants n=800 Participants
Clinical Frailty Scale score 3 Controlled medical issues, walk only	11 Participants n=49 Participants	210 Participants n=751 Participants	221 Participants n=800 Participants
Clinical Frailty Scale score 4 Symptoms limit activities	5 Participants n=49 Participants	113 Participants n=751 Participants	118 Participants n=800 Participants
Clinical Frailty Scale score 5 Need help with daily living activities^	2 Participants n=49 Participants	69 Participants n=751 Participants	71 Participants n=800 Participants
Clinical Frailty Scale score 6 Need help with bathing/dressing	9 Participants n=49 Participants	53 Participants n=751 Participants	62 Participants n=800 Participants
Clinical Frailty Scale score 7-8 Completely dependent for everything	9 Participants n=49 Participants	44 Participants n=751 Participants	53 Participants n=800 Participants
Clinical Frailty Scale score 9 Terminally ill, life expectancy < 6 months	1 Participants n=49 Participants	7 Participants n=751 Participants	8 Participants n=800 Participants
Abnormal neurological examination from baseline	19 Participants n=49 Participants	17 Participants n=751 Participants	36 Participants n=800 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Patients Need Head CT According to Falls Decision Rule n=559 Participants Based on the Falls Decision Rule, a head CT scan is recommended for patients who meet any of the following criteria: * History of head trauma during the fall. * New abnormalities on neurological examination upon ED presentation. * Memory loss (amnesia) regarding the events surrounding the fall. * Clinical Frailty Scale score of 5 or higher.	Patients do Not Need Head CT According to Falls Decision Rule n=241 Participants Based on the Falls Decision Rule, patients who do not require a head CT scan must meet all of the following criteria: * No history of head trauma during the fall. * No new abnormalities on neurological examination. * No memory loss (amnesia) regarding the events surrounding the fall. * A Clinical Frailty Scale score of less than 5.
Number of Participants With the Clinically Important Intracranial Bleeding	48 Participants	1 Participants

SECONDARY outcome

Timeframe: 42 day

Neurosurgical intervention was defined as any surgical procedure performed to manage clinically important intracranial bleeding (CIIB) identified either at the initial emergency department visit or during the 42-day follow-up period.

Outcome measures

Outcome measures
Measure	Patients Need Head CT According to Falls Decision Rule n=49 Participants Based on the Falls Decision Rule, a head CT scan is recommended for patients who meet any of the following criteria: * History of head trauma during the fall. * New abnormalities on neurological examination upon ED presentation. * Memory loss (amnesia) regarding the events surrounding the fall. * Clinical Frailty Scale score of 5 or higher.	Patients do Not Need Head CT According to Falls Decision Rule n=751 Participants Based on the Falls Decision Rule, patients who do not require a head CT scan must meet all of the following criteria: * No history of head trauma during the fall. * No new abnormalities on neurological examination. * No memory loss (amnesia) regarding the events surrounding the fall. * A Clinical Frailty Scale score of less than 5.
Number of Participant With Neurosurgical Intervention	6 Participants	0 Participants

SECONDARY outcome

Timeframe: 42 day

Mortality was defined as death occurring at any point during the 42-day follow-up period, regardless of whether it was directly attributed to clinically important intracranial bleeding (CIIB). Deaths were identified through national healthcare system.

Outcome measures

Outcome measures
Measure	Patients Need Head CT According to Falls Decision Rule n=49 Participants Based on the Falls Decision Rule, a head CT scan is recommended for patients who meet any of the following criteria: * History of head trauma during the fall. * New abnormalities on neurological examination upon ED presentation. * Memory loss (amnesia) regarding the events surrounding the fall. * Clinical Frailty Scale score of 5 or higher.	Patients do Not Need Head CT According to Falls Decision Rule n=751 Participants Based on the Falls Decision Rule, patients who do not require a head CT scan must meet all of the following criteria: * No history of head trauma during the fall. * No new abnormalities on neurological examination. * No memory loss (amnesia) regarding the events surrounding the fall. * A Clinical Frailty Scale score of less than 5.
Number of Patients With Mortality	12 Participants	34 Participants

Adverse Events

Patients Identified With CIIB on Initial Visit and 42 Day Follow-up

Serious events: 0 serious events

Other events: 0 other events

Deaths: 12 deaths

Patients Without CIIB

Serious events: 0 serious events

Other events: 0 other events

Deaths: 34 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Emre Kudu

Marmara University School of Medicine

Phone: +902166254545

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place