- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03878043
Factors Influencing Readmission Rates of Acute Traumatic Subdural Hematoma in the Elderly
March 19, 2019 updated by: Tarik Wasfie, MD
A Retrospective Analysis of Factors Influencing Readmission Rates of Acute Traumatic Subdural Hematoma in the Elderly
Acute traumatic subdural hematomas (TSDH) readmission rate is high (27.8%)
with an increase in morbidity and cost for the elderly.
This study identifies risk factors affecting readmission rates for these patients and presents strategies to reduce it.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A retrospective analysis was conducted on patients with traumatic brain injuries (ICD-9-CM codes 800.20 - 801.86, 852.00 - 853.05) admitted between 2014 and 2016 at Genesys Regional Medical Center through the trauma service.
From this group, the investigators selected patients admitted with traumatic SDH, and those patients were followed over the following 6 months as regards to readmission status.
Patients who were readmitted versus patients who were not readmitted were compared.
The risk of readmission within 6 months of discharge for SDH was analyzed adjusting for age, prior anticoagulation use, Injury Severity Score (ISS), Glasgow Coma Scale (GCS), gender, time to readmission and co-morbid conditions which included diabetes mellitus, cardiovascular disease, renal disease, chronic obstructive pulmonary disease, and osteoporotic/orthopedic fractures using Cox Proportional Hazards Regression analysis.
Study Type
Observational
Enrollment (Actual)
167
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Grand Blanc, Michigan, United States, 48439
- Genesys Regional Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 105 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients admitted to a Community General Hospital who were diagnosed with a Traumatic Subdural Hematoma.
Description
Inclusion Criteria:
- Patients diagnosed with Traumatic Subdural Hematoma during time of study
Exclusion Criteria:
- Patients who expired.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients without Readmissions
Patients with TSDH who were not readmitted within a 6-month time period following their initial visit.
|
|
Patients with Readmissions
Patients with TSDH who were readmitted within a 6-month time period following their initial visit.
|
Follow up care provided upon readmission to patients who were diagnosed with a TSDH upon initial visit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants readmitted to the hospital
Time Frame: 6 months
|
Number of patients diagnosed with TSDH who were readmitted to the hospital within a 6 month time frame
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tarik Wasfie, MD, Ascension Genesys Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2014
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
March 1, 2019
Study Registration Dates
First Submitted
March 14, 2019
First Submitted That Met QC Criteria
March 14, 2019
First Posted (Actual)
March 18, 2019
Study Record Updates
Last Update Posted (Actual)
March 21, 2019
Last Update Submitted That Met QC Criteria
March 19, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Hemorrhage
- Craniocerebral Trauma
- Trauma, Nervous System
- Intracranial Hemorrhages
- Intracranial Hemorrhage, Traumatic
- Hematoma
- Hematoma, Subdural
- Hematoma, Subdural, Intracranial
Other Study ID Numbers
- GRMC 160013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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