Acute Cardiac Responses to Spinal Cord Injury

NCT03143179 | Unknown DMC

• 1 other identifier: H16-00818
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The immediate period after spinal cord injury (SCI) is one of the only opportunities that clinicians and care-givers have to make a real difference to patient outcomes. One of the main aims during this period is to preserve blood flow and oxygen delivery to the spinal cord to prevent any further damage from occurring after the injury. The heart acts as the major pump for blood to be pumped to the spinal cord and the body. It has been shown in small animal models and in humans with long-standing SCI that the ability of the heart to pump blood after injury is compromised, which may in turn reduce the amount of blood and oxygen delivered to the injured cord. It is unclear how quickly these changes occur in the heart following SCI and how best to manage heart function such that blood flow and oxygen delivery can be optimized. In the present study, the investigators will examine how the heart functions immediately after SCI. The findings from this study are expected to provide new information that could help clinicians improve the management of people who have just suffered a SCI.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• daily resting ejection fraction

  Index of systolic cardiac function

  up to 3 days

Secondary Outcomes (1)

• slope of the Starling curve

  up to 3 days

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

10 individuals aged 18-60 who have sustained an acute traumatic SCI above T2 spinal level less than 72hours prior.

You may qualify if:

• Male or Female aged 18-60yrs
• Acute traumatic SCI at T2 or above within the last 72 hours
• Complete (American Spinal Injuries Association Impairment Scale (AIS) A) or incomplete (AIS B) initial designation
• Requires insertion of central venous catheter and arterial catheter as part of standard clinical care
• Able to communicate in English and provide informed consent
• in sinus rhythm.

You may not qualify if:

• History and/or symptoms of cardiovascular disease or cardiopulmonary problems/disease, including controlled/uncontrolled hypertension
• Historical or current nasal injury (incl. cosmetic surgery)
• Nasal polyps
• Concurrent facial trauma
• Traumatic brain injury
• Concurrent intra-aortic balloon pump
• Carcinoma/major surgery of the pharynx, larynx or esophagus
• Aneurysms of the thoracic aorta
• Tissue necrosis of the esophagus or nasal passage
• Any other medical condition that in the investigator's opinion would render the study procedures dangerous.

Sponsors & Collaborators

• University of British Columbia: lead
• United States Department of Defense: collaborator

Study Sites (1)

Vancouver General Hospital

Vancouver, Canada

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Christopher West, PhD

CONTACT

250.807.8891; chris.west@ubc.ca

Erin Erskine

CONTACT

604-809-5827; erin.erskine@ubc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 8, 2017
• Study Start: May 16, 2018
• Primary Completion: October 1, 2021
• Study Completion: September 30, 2022
• Last Updated: August 24, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)