Appropriateness of Methodist Health System(MHS) Inter-facility Transfers of Traumatic Intracranial Subarachnoid Hemorrhage and Spontaneous Bleeds for Level-1 Advanced Surgical Intervention

November 15, 2023 updated by: Methodist Health System

Appropriateness of MHS Inter-facility Transfers of Traumatic Intracranial Subarachnoid Hemorrhage and Spontaneous Bleeds for Level-1 Advanced Surgical Intervention

Brain injuries are common and challenging problems faced by emergency physicians. These diagnoses may include traumatic intracerebral hemorrhage, subarachnoid hemorrhage, ruptured cerebral aneurysms, unruptured cerebral aneurysms, and arteriovenous malformations, which require neurological, neurosurgical, and/or endovascular treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Brain injuries are common and challenging problems faced by emergency physicians. These diagnoses may include traumatic intracerebral hemorrhage, subarachnoid hemorrhage, ruptured cerebral aneurysms, unruptured cerebral aneurysms, and arteriovenous malformations, which require neurological, neurosurgical, and/or endovascular treatment. Depending on the indication and its severity, transfer to a comprehensive stroke center for access to advanced neuro-critical care may be necessary. Comprehensive stroke centers are widely supported and have the resources and infrastructure to have in-house expert stroke providers, teams, operating rooms, and interventional radiology suites that are always available.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bethany Brauer, MPH
  • Phone Number: 74681 214-947-4681
  • Email: mhsirb@mhd.com

Study Contact Backup

  • Name: Colette Ngo Ndjom, MS
  • Phone Number: 71289 214) 947-1289
  • Email: MHSIRB@mhd.com

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75203
        • Recruiting
        • Clinical Research Institute at Methodist Health System
        • Principal Investigator:
          • Richard Meyrat, MD
        • Contact:
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Methodist Mansfield Medical Center and Methodist Charlton Medical Center to Methodist Dallas Medical Center for patients experiencing traumatic intracranial subarachnoid hemorrhage or spontaneous bleeds

Description

Inclusion Criteria:

  • Patients ≥18 years old
  • Diagnosed with traumatic intracranial subarachnoid hemorrhage or a spontaneous bleed
  • Patients originating at Methodist Mansfield medical center (MMMC) or Methodist Charlton medical center(MCMC)and subsequently transferred to Methodist Dallas medical center (MDMC)

Exclusion Criteria:

  • Does not meet inclusion criteria defined in section 3.1

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the historical rate of appropriate and inappropriate Methodist interfacility transfers for patients experiencing traumatic intracranial subarachnoid hemorrhage or spontaneous bleed.
Time Frame: 3 days
Implementation of screening protocols and standardization for interfacility transfers may help to reduce the incidence of unnecessary transfers.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Health System

Investigators

  • Principal Investigator: Richard Meyrat, MD, Methodist Dallas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 20, 2022

Primary Completion (Estimated)

June 20, 2024

Study Completion (Estimated)

June 20, 2024

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

November 15, 2023

First Posted (Estimated)

November 16, 2023

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101.MBSI.2022.A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study data or any protected health information will not be shared with anyone that is not delegated to the study. The PI is committed to disseminate research results in a timely fashion. Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals. All information obtained will be source de-identified and presented on a large scale and not traceable to any one particular individual.

IPD Sharing Time Frame

2 years

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

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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