Spinal Cord InjuriesNCT03143179
Acute Cardiac Responses to Spinal Cord Injury
An observational study of Spinal Cord Injuries, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 16 May 2018to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 10 individuals aged 18-60 who have sustained an acute traumatic SCI above T2 spinal level less than 72hours prior.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Vancouver General Hospital
Vancouver
Leilani Reichl, Leilani.Reichl@vch.ca
About this study
Official title: Acute Hemodynamic and Cardiac Responses to Spinal Cord Injury: A Feasibility Study
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.
Read the detailed description
Background:
The hemodynamic management of the cervical/high-thoracic spinal cord injured patient represents a remarkably complex clinical scenario, but represents one of the only potentially neuroprotective therapeutic options currently available to the clinician. Presently, the singular goal of hemodynamic management is to increase mean arterial blood pressure (MAP) to 85mmHg by targeting peripheral tone via vasopressor therapy, with a view to increasing perfusion of the spinal cord, preventing ischemia at the injury site, and optimizing neurological outcome. It is often overlooked that the instantaneous removal of descending sympathetic control at the time of SCI renders not only the vast majority of the systemic vasculature devoid of supraspinal input, but it also impairs descending control of the heart. What is yet to be considered in current hemodynamic management protocols is that immediate cardiac dysfunction secondary to impaired supraspinal control of the heart may very well be a significant contributor to poor spinal cord perfusion. Indeed, data collected over the last four years in rodent SCI models suggests that cardiac sympathetic decentralization is the principal cause of the low cardiac output observed in both rodents and people with chronic SCI. As such, the investigator's initiative is to provide a novel approach to hemodynamic management to a porcine model that harnesses both peripheral tone and cardiac function. The investigators believe this approach is an immediately translatable neuroprotective strategy for acute SCI.
Overview:
10 individuals aged 18-60 who have sustained an acute traumatic SCI (above T2 spinal level) less than 72 hours prior will be recruited over a period of 2 years. Recruitment will be isolated to those individuals who already have a central venous catheter and arterial line as part of standard clinical care (which actually occurs in most patients). In addition to standard clinical lines, an esophageal Doppler probe will be placed to measure aortic outflow on which beat-by-beat systolic cardiac function (i.e., stroke volume, cardiac output, ejection fraction) can be estimated. During a 120 min monitoring period, beat-by-beat dependent cardiac indices will be recorded and a modified Starling curve will be constructed by examining relationships between central venous pressure (i.e., an index of venous return) and aortic flow (i.e., an index of cardiac output). After 1hr of monitoring (Part A), a 250ml bolus of intravenous crystalloid will be infused over a 5 min period and measure beat-by-beat central venous pressure and aortic flow (stroke volume) responses (Part B). The primary outcomes are daily resting stroke volume and ejection fraction, change in stroke volume and central venous pressure (CVP) in response to fluid challenge. The secondary outcome is the slope of the Starling curve
- Conditions
- Spinal Cord Injuries
- Medical subject headings
- Spinal Cord Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
daily resting ejection fraction
Index of systolic cardiac function
Measured: up to 3 days
Secondary outcomes (1)
slope of the Starling curve
Slope of the central venous pressure vs. cardiac output curve derived from the fluid challenge
Measured: up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start16 May 2018
- Primary completion1 Oct 2021 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Christopher West, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143179
- Sponsor's protocol ID
- H16-00818
- Status last verified
- Aug 2020
- First submitted
- 2 May 2017
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Hemodynamic and Cardiac Responses to Spinal Cord Injury: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03143179
- Acronym / sponsor ID
- H16-00818
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 16 May 2018 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
The hemodynamic management of the cervical/high-thoracic spinal cord injured patient represents a remarkably complex clinical scenario, but represents one of the only potentially neuroprotective therapeutic options currently available to the clinician. Presently, the singular goal of hemodynamic management is to increase mean arterial blood pressure (MAP) to 85mmHg by targeting peripheral tone via vasopressor therapy, with a view to increasing perfusion of the spinal cord, preventing ischemia at the injury site, and optimizing neurological outcome. It is often overlooked that the instantaneous removal of descending sympathetic control at the time of SCI renders not only the vast majority of the systemic vasculature devoid of supraspinal input, but it also impairs descending control of the heart. What is yet to be considered in current hemodynamic management protocols is that immediate cardiac dysfunction secondary to impaired supraspinal control of the heart may very well be a significant contributor to poor spinal cord perfusion. Indeed, data collected over the last four years in rodent SCI models suggests that cardiac sympathetic decentralization is the principal cause of the low cardiac output observed in both rodents and people with chronic SCI. As such, the investigator's initiative is to provide a novel approach to hemodynamic management to a porcine model that harnesses both peripheral tone and cardiac function. The investigators believe this approach is an immediately translatable neuroprotective strategy for acute SCI.
Overview:
10 individuals aged 18-60 who have sustained an acute traumatic SCI (above T2 spinal level) less than 72 hours prior will be recruited over a period of 2 years. Recruitment will be isolated to those individuals who already have a central venous catheter and arterial line as part of standard clinical care (which actually occurs in most patients). In addition to standard clinical lines, an esophageal Doppler probe will be placed to measure aortic outflow on which beat-by-beat systolic cardiac function (i.e., stroke volume, cardiac output, ejection fraction) can be estimated. During a 120 min monitoring period, beat-by-beat dependent cardiac indices will be recorded and a modified Starling curve will be constructed by examining relationships between central venous pressure (i.e., an index of venous return) and aortic flow (i.e., an index of cardiac output). After 1hr of monitoring (Part A), a 250ml bolus of intravenous crystalloid will be infused over a 5 min period and measure beat-by-beat central venous pressure and aortic flow (stroke volume) responses (Part B). The primary outcomes are daily resting stroke volume and ejection fraction, change in stroke volume and central venous pressure (CVP) in response to fluid challenge. The secondary outcome is the slope of the Starling curve
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 10 individuals aged 18-60 who have sustained an acute traumatic SCI above T2 spinal level less than 72hours prior.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
daily resting ejection fraction
Time frame: up to 3 days
Index of systolic cardiac function
1 secondary outcome
slope of the Starling curve
Time frame: up to 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher West, PhD (250.807.8891, chris.west@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
daily resting ejection fraction (time frame: up to 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020; AzTrials last refreshed its copy on 26 Oct 2026.