RECRUITING

Hemodynamic Management Following Acute Traumatic Spinal Cord Injury

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to assess the effect of various hemodynamic management strategies on functional neurologic outcomes and non-neurologic adverse events in the first 5 days following acute spinal cord injury (SCI). The hemodynamic management strategies assessed include targeting a mean arterial blood pressure (MAP) goal of 85-90 mmHg, targeting a spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg, or targeting normal hemodynamics, which is a MAP goal of ≥65 mmHg.

Official Title

Hemodynamic Management Following Acute Traumatic Spinal Cord Injury: A Randomized, Controlled Trial

Quick Facts

Study Start:2024-07-03
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06451133

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Traumatic spinal cord injury
  1. * Patients with an injury from a trauma that penetrates the spinal cord (i.e., gunshot or knife wound resulting in cord transection)
  2. * Preexisting neurologic or spinal cord injury
  3. * Severe traumatic brain injury as measured by a best resuscitated Glasgow Coma Scale (GCS) score of \<8 at 24 hours following injury
  4. * Presence of traumatic injuries that preclude spine surgery within 24 hours of presentation
  5. * Concomitant injury/illness requiring targeted blood pressure management (e.g., injury to the aorta, aortic dissection, hemorrhagic stroke)
  6. * Preexisting history of neuromotor disorders (i.e., cerebral palsy, Parkinson disease, etc.)
  7. * Not expected to survive \>24h
  8. * Cord transection identified by radiologist and agreed upon by the spine surgery team
  9. * Injury below spinal cord level L1
  10. * Prisoners
  11. * Pregnant women

Contacts and Locations

Study Contact

David Meyer, MD, MS, FACS
CONTACT
(713) 500-7244
David.E.Meyer@uth.tmc.edu
Erin Fox
CONTACT
(713) 500-6273
Erin.E.Fox@uth.tmc.edu

Principal Investigator

David Meyer, MD, MS, FACS
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston

Study Locations (Sites)

The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

  • David Meyer, MD, MS, FACS, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

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 Registration Dates

Study Start Date2024-07-03
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2024-07-03
Study Completion Date2026-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Spinal Cord Injuries