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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03878043
Other study ID # GRMC 160013
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2014
Est. completion date March 2019

Study information

Verified date March 2019
Source Genesys Regional Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 167
Est. completion date March 2019
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 105 Years
Eligibility Inclusion Criteria:

- Patients diagnosed with Traumatic Subdural Hematoma during time of study

Exclusion Criteria:

- Patients who expired.

Study Design


Intervention

Other:
Follow-up Care
Follow up care provided upon readmission to patients who were diagnosed with a TSDH upon initial visit.

Locations

Country Name City State
United States Genesys Regional Medical Center Grand Blanc Michigan

Sponsors (1)

Lead Sponsor Collaborator
Tarik Wasfie, MD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 months