Recruiting

MAP with Anticoagulants

Sponsor:

University of British Columbia

Code:

NCT04758377

Conditions

Traumatic Spinal Cord Haemorrhage

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Magnetic resonance imaging (MRI)

Study Details

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).

Conditions

Traumatic Spinal Cord Haemorrhage

Study ID

NCT04758377

Start date

Feb 6, 2021

Status verified date

Jun, 2023

Completion date

Jun 1, 2025

Anticipated

Primary completion date

Jun 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Arm 1

Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage.

Interventions

Magnetic resonance imaging (MRI)

Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage.

Primary outcome measure

  • Hemorrhage Quantification 1 [ Time Frame: Serial MRI assessments: Injury to 2 weeks post injury ]
  • Hemorrhage Quantification 2 [ Time Frame: Serial MRI assessments: Injury to 2 weeks post injury ]
  • Hemorrhage Quantification 3 [ Time Frame: Serial MRI assessments: Injury to 2 weeks post injury ]
  • Hemorrhage Quantification 4 [ Time Frame: Serial MRI assessments: Injury to 2 weeks post injury ]

Central Contacts and Locations

Central contacts

Allan Aludino

604-875-4111allan.aludino@vch.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada

Contacts

Allan Aludino

604-875-4111

More Information

Sponsor

University of British Columbia

Last update posted

Jul 3, 2023

Last verified

Jun, 2023

Keywords

  • vasopressors
  • magnetic resonance imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2023-07-03.