Characterizing Hemorrhage in Acute Spinal Cord Injury Wit... | NCT04758377

Studies
Characterizing Hemorrhage in Acute Spinal Cord Injury With MRI

NCT04758377

Sponsor

University of British Columbia

Status

Unknown status

Last Update Posted

Jul 3, 2023Actual

Enrollment

24Estimated

Phase

Not Applicable

Conditions

Traumatic Spinal Cord Haemorrhage

Interventions

Magnetic resonance imaging (MRI)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 6, 2021Actual

Primary Completion Date

Jun 1, 2024Estimated

Completion Date

Jun 1, 2025Estimated

First Submitted Date

Feb 12, 2021

First Submission Date that Met QC Criteria

Feb 16, 2021

First Posted Date

Feb 17, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2023

Last Update Posted Date

Jul 3, 2023Actual

Name	Class
United States Department of Defense	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study is designed to determine whether hemorrhage within the injured spinal cord is influenced by mean arterial pressure (MAP) augmentation with vasopressors and by venous thromboembolism (VTE) prophylaxis with anticoagulants in the first two weeks following a traumatic spinal cord injury (tSCI).

Detailed Description

This will be a single-center prospective observational study of patients with an acute cervical traumatic spinal cord injury

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage.	Procedure: Magnetic resonance imaging (MRI)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnetic resonance imaging (MRI)	Procedure	Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage.	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemorrhage Quantification 1	Area of hematoma	Serial MRI assessments: Injury to 2 weeks post injury
Hemorrhage Quantification 2	Vertical length of hematoma and vertical length of cord edema	Serial MRI assessments: Injury to 2 weeks post injury
Hemorrhage Quantification 3	The point of maximum cord compression vertebral level and anatomic point of maximum cord compression vertebral sublevel	Serial MRI assessments: Injury to 2 weeks post injury
Hemorrhage Quantification 4	Vertical length of cord edema rostral to maximum compression and vertical length of cord edema caudal to maximum compression.	Serial MRI assessments: Injury to 2 weeks post injury

Secondary Outcomes

Measure	Description	Time Frame
Hemodynamic Management Assessment 1	achieved mean arterial pressure	Injury to 2 weeks post injury
Hemodynamic Management Assessment 2	vasopressor usage/dose

Other Outcomes

Measure	Description	Time Frame
Neurologic Assessments	International Standards for Neurological Classification of SCI (ISNCSCI)	Injury to 6 months post injury

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute tSCI injury involving bony spinal levels between C0 and T1
Baseline Asia Impairment Scale (AIS) grade of A, B, or C
Admission to study site within 24 hours of injury
Male or female age 19 or older
Able and willing to provide informed consent

Exclusion Criteria:

Pathological fracture due to metabolic condition or neoplasia
Spinal cord injury due to infection
Presence of pacemaker, aneurysm clip or other device which is a contraindication to MRI
BMI > 40 and unable to fit within the MRI scanner
Multiple life threatening injuries (ISS >16) that make transport to MRI not in the patient's best interest
Any condition that, at the time of admission, prevents a complete ISNCSCI assessment from being performed

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Allan Aludino	Contact	604-875-4111	61689	allan.aludino@vch.ca

Overall Officials

Name	Affiliation	Role
Brian Kwon, MD	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vancouver General Hospital	Recruiting	Vancouver	British Columbia		Canada

Intervention Browse Module

MeSH Terms

ID	Term
D009682	Magnetic Resonance Spectroscopy

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

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Browse Branches

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