Traumatic Subdural HematomaNCT03878043
Factors Influencing Readmission Rates of Acute Traumatic Subdural Hematoma in the Elderly
An observational study of Traumatic Subdural Hematoma, run by Tarik Wasfie, MD at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Subdural Hematoma
- What is being tested?
- Follow-up Care
- How many people
- 167 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients admitted to a Community General Hospital who were diagnosed with a Traumatic Subdural Hematoma.
Who may be able to join
- Patients diagnosed with Traumatic Subdural Hematoma during time of study
Who cannot join
- Patients who expired.
Trial locations and contacts
1 site in 1 country.
United States1 site
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
About this study
Official title: 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.
Read the 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.
- Conditions
- Traumatic Subdural Hematoma
- Being tested
- Follow-up Care
- Keywords
- subdural hematoma, readmission, risk factors
- Medical subject headings
- Hematoma, Subdural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up CareOther
Follow up care provided upon readmission to patients who were diagnosed with a TSDH upon initial visit.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Follow-up Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants readmitted to the hospital
Number of patients diagnosed with TSDH who were readmitted to the hospital within a 6 month time frame
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study startJan 2014
- Primary completionDec 2016
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Subdural HematomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarik Wasfie, MD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Tarik Wasfie, MD, Ascension Health
- Investigators
- Tarik Wasfie, MD, Principal investigator, Ascension Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878043
- Sponsor's protocol ID
- GRMC 160013
- Status last verified
- Mar 2019
- First submitted
- 14 Mar 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis of Factors Influencing Readmission Rates of Acute Traumatic Subdural Hematoma in the Elderly
- ClinicalTrials.gov ID
- NCT03878043
- Acronym / sponsor ID
- GRMC 160013
- Conditions
- Traumatic Subdural Hematoma
- Keywords
- subdural hematoma, readmission, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Tarik Wasfie, MDIndustry (pharma, biotech, devices)
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without Readmissions | – | –Patients with TSDH who were not readmitted within a 6-month time period following their initial visit. |
| Patients with Readmissions | – | Other: Follow-up CarePatients with TSDH who were readmitted within a 6-month time period following their initial visit. |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to a Community General Hospital who were diagnosed with a Traumatic Subdural Hematoma.
Key inclusion criteria (1 listed)
- Patients diagnosed with Traumatic Subdural Hematoma during time of study
Key exclusion criteria (1 listed)
- Patients who expired.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow-up CareFollow up care provided upon readmission to patients who were diagnosed with a TSDH upon initial visit. | Other | Patients with Readmissions |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarik Wasfie, MD principal investigator
Ascension Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Subdural Hematoma, run by Tarik Wasfie, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants readmitted to the hospital (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.