Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525727
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Validation of Falls Decision Rule to Exclude Intracranial Bleeding in Geriatric Fall Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
External Validation of the Falls Decision Rule to Exclude Intracranial Bleeding Without Head CT in Geriatric Patients Presenting to the Emergency Department With A Fall
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
In the geriatric population 65 years falls are responsible for 70 of traumatic brain injury Computed tomography CT evaluation of the brain used in evaluating these patients makes it possible to detect intracranial hemorrhage in the early period Thus it plays a critical role in initiating timely and necessary interventions These interventions include blood pressure control hemorrhage control and neurosurgical interventions
Although the most important cause of intracranial hemorrhage in this population is falls studies have shown that bleeding occurs in only 5 of geriatric patients who fall Therefore it is inefficient and costly to perform brain CT evaluation in every patient
Rules have been developed to assist the clinician in identifying patients at risk of intracranial hemorrhage which has a relatively low incidence but significant morbidity and mortality The Canadian Brain CT rule one of the most widely used rules for this purpose determines the need for brain CT in patients with head trauma However this rule applies to patients with disorientation amnesia or loss of consciousness There are insufficient studies to guide neuroimaging for older adults who hit their heads while falling but do not experience these symptoms In addition guidance from the literature for older adults who fall but cannot describe what happened or did not hit their heads is also insufficient The Falls Decision Rule was developed by de Wit et al in 2023 to assess the need for CT in this patient group This criterion was developed by including a total of 4308 patients in the United States and Canadian emergency departments It suggests that in patients in the geriatric population there is no need for Brain CT in the absence of significant head trauma due to falls no memory loss due to falls no newly developing neurological examination disorder and a clinical frailty score of less than 5 The sensitivity of this score to exclude clinically significant bleeding is 986 95 CI 949-996 and the negative predictive value is 998 95 CI 992-998
This newly developed rule was developed only in a specific geographical region In this study external validation of this newly developed score was planned in order to evaluate its safety applicability and accuracy
Patients over 65 years of age who come to the emergency department with a fall will be observationally recorded on the case form after obtaining consent from the patient or hisher relatives and will be followed up for clinically significant intracranial hemorrhage within 42 days This study is a validation study and the protocol used in the original study will be followed The study is a prospective observational study The study will start after ethics committee approval and will be conducted at Marmara University Pendik Training and Research Hospital The data collection process will be completed when the targeted sample size is reached
The sample size was calculated for the diagnostic value study planned to validate the fall decision rule developed by de Wit et al to rule out patients with intracranial hemorrhage Using the incidence sensitivity and specificity values shared by the authors as a reference the minimum sample size to be included in the study was calculated as 663 with 80 power and 005 margin of error Considering the risk of missing and inaccurate measurements the target sample size was increased by 15 and set as 763
Data will be obtained from patient files Hospital Information Management System and PACS systems Demographic information age gender Known diseases HT DM AF CHF etc Information on falls Physical examination information Consultation notes if any Antiplatelet anticoagulant use Frailty score The CT scan results will be saved
Patients will be followed up for delayed intracranial hemorrhage within 42 days after the fall as in the original study Also as in the methodology of the original study patients will be followed up through the electronic information system Previous studies have shown that this method has a low sensitivity 37 95 CI 21-56 for intracranial hemorrhage when patients are questioned for intracranial hemorrhage by telephone call Therefore in the original study and this study it was planned to follow up the information of the patients from the electronic information system records instead of telephoning The intracranial hemorrhage status of the patients within 42 days will be followed up through the hospital information system and patient information system
Although the most important cause of intracranial hemorrhage in this population is falls studies have shown that bleeding occurs in only 5 of geriatric patients who fall Therefore it is inefficient and costly to perform brain CT evaluation in every patient
Rules have been developed to assist the clinician in identifying patients at risk of intracranial hemorrhage which has a relatively low incidence but significant morbidity and mortality The Canadian Brain CT rule one of the most widely used rules for this purpose determines the need for brain CT in patients with head trauma However this rule applies to patients with disorientation amnesia or loss of consciousness There are insufficient studies to guide neuroimaging for older adults who hit their heads while falling but do not experience these symptoms In addition guidance from the literature for older adults who fall but cannot describe what happened or did not hit their heads is also insufficient The Falls Decision Rule was developed by de Wit et al in 2023 to assess the need for CT in this patient group This criterion was developed by including a total of 4308 patients in the United States and Canadian emergency departments It suggests that in patients in the geriatric population there is no need for Brain CT in the absence of significant head trauma due to falls no memory loss due to falls no newly developing neurological examination disorder and a clinical frailty score of less than 5 The sensitivity of this score to exclude clinically significant bleeding is 986 95 CI 949-996 and the negative predictive value is 998 95 CI 992-998
This newly developed rule was developed only in a specific geographical region In this study external validation of this newly developed score was planned in order to evaluate its safety applicability and accuracy
Patients over 65 years of age who come to the emergency department with a fall will be observationally recorded on the case form after obtaining consent from the patient or hisher relatives and will be followed up for clinically significant intracranial hemorrhage within 42 days This study is a validation study and the protocol used in the original study will be followed The study is a prospective observational study The study will start after ethics committee approval and will be conducted at Marmara University Pendik Training and Research Hospital The data collection process will be completed when the targeted sample size is reached
The sample size was calculated for the diagnostic value study planned to validate the fall decision rule developed by de Wit et al to rule out patients with intracranial hemorrhage Using the incidence sensitivity and specificity values shared by the authors as a reference the minimum sample size to be included in the study was calculated as 663 with 80 power and 005 margin of error Considering the risk of missing and inaccurate measurements the target sample size was increased by 15 and set as 763
Data will be obtained from patient files Hospital Information Management System and PACS systems Demographic information age gender Known diseases HT DM AF CHF etc Information on falls Physical examination information Consultation notes if any Antiplatelet anticoagulant use Frailty score The CT scan results will be saved
Patients will be followed up for delayed intracranial hemorrhage within 42 days after the fall as in the original study Also as in the methodology of the original study patients will be followed up through the electronic information system Previous studies have shown that this method has a low sensitivity 37 95 CI 21-56 for intracranial hemorrhage when patients are questioned for intracranial hemorrhage by telephone call Therefore in the original study and this study it was planned to follow up the information of the patients from the electronic information system records instead of telephoning The intracranial hemorrhage status of the patients within 42 days will be followed up through the hospital information system and patient information system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None