NCT03878043

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

2.9 years

First QC Date

March 14, 2019

Last Update Submit

March 19, 2019

Conditions

Traumatic Subdural Hematoma

Keywords

subdural hematomareadmissionrisk factors

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Other: Follow-up Care

Interventions

Follow-up CareOTHER

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

Patients with Readmissions

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to a Community General Hospital who were diagnosed with a Traumatic Subdural Hematoma.

You may qualify if:

  • Patients diagnosed with Traumatic Subdural Hematoma during time of study

You may not qualify if:

  • Patients who expired.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

MeSH Terms

Conditions

Hematoma, Subdural

Interventions

Aftercare

Condition Hierarchy (Ancestors)

Intracranial Hemorrhage, TraumaticIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemVascular DiseasesCardiovascular DiseasesHematomaHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Intervention Hierarchy (Ancestors)

Continuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesPrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Tarik Wasfie, MD

    Ascension Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Department of Trauma Surgery

Study Record Dates

First Submitted

March 14, 2019

First Posted

March 18, 2019

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Study Completion

March 1, 2019

Last Updated

March 21, 2019

Record last verified: 2019-03

Locations

US(1)