NCT03911492

Brief Summary

This multicenter study will enroll 100 patients with acute traumatic cervical and thoracic SCI who have a lumbar intrathecal catheter inserted within 24 hours of their injury. The lumbar intrathecal catheter will be inserted pre-operatively for the measurement of ITP and the collection of cerebrospinal fluid (CSF) samples. SCPP will be calculated as the difference between MAP and the ITP. There are two important distinct yet related objectives in this prospective interventional study.

  1. 1.Determine the effect of SCPP maintenance ≥ 65 mmHg in acute SCI on neurologic recovery as measured by ASIA Impairment Scale (AIS) grade conversion and motor score improvement.
  2. 2.Collect CSF and blood samples for the measurement of neurochemical biomarkers and storage for future biomarker discovery and validation studies.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
2 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

August 31, 2019

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

5.5 years

First QC Date

April 9, 2019

Last Update Submit

June 30, 2023

Conditions

Acute Spinal Cord InjuryAcute Spinal ParalysisSpinal Cord InjuriesSPINAL Fracture

Keywords

SCISpinal Cord InjuryCSFBiomarkerCSF pressureTraumatic SCIPerfusion pressure

Outcome Measures

Primary Outcomes (1)

  • International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination

    Neurologic recovery over time will be measured using the ISNCSCI examination - at Baseline, Days 1-7, and months 3, 6 and 12. Our primary outcome measure will be the change in total motor score at 6 months post-injury (a time point at which most motor recovery has occurred and is commonly used in acute SCI clinical trials).

    12 months

Secondary Outcomes (2)

  • Levels of specific biochemical markers in CSF and Blood

    7 days

  • Spinal Cord Perfusion Pressure (SCPP)

    7 days

Study Arms (1)

SCP Pressure Management

OTHER

Active management of Spinal Cord Perfusion Pressure (SCPP) at or above 65 mmHg.

Procedure: SCPP Management => 65 mmHg

Interventions

SCPP Management => 65 mmHgPROCEDURE

A lumbar intrathecal catheter will be inserted pre-operatively for the measurement of Intrathecal pressure (ITP) and the collection of cerebrospinal fluid (CSF) samples. SCPP will be calculated as the difference between Mean Arterial Pressure (MAP) and the ITP.

SCP Pressure Management

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female ≥ 17 (or the provincial age of majority - depending on local REB guidelines)
  • Complete (AIS A) or incomplete (AIS B, C) acute traumatic spinal cord injury.
  • Bony spinal levels between C0 and T12 inclusive.
  • Blunt (non-penetrating) spinal cord injury treated either surgically or non-surgically
  • Lumbar intrathecal catheter to be inserted as part of clinical hemodynamic management and CSF sample collected within 48 hours of injury
  • Initial blood sample collected within 24 hours of injury

You may not qualify if:

  • Motor incomplete spinal cord injury AIS D (i.e. at least half (half or more) of the key muscle functions below the neurological level of injury (NLI) have a muscle grade greater than or equal to 3/5)
  • Spinal cord injury with sensory deficit only (i.e. no motor deficit)
  • Penetrating spinal cord injury (including gunshot wounds)
  • Isolated radiculopathy
  • Isolated cauda equina injury or spinal injury below L1
  • Associated injury (soft tissue or bony) to the lumbar spine where the intrathecal catheter would be placed
  • Associated traumatic conditions that would interfere with the outcome assessment (e.g., traumatic brain injury, chest, pelvis, abdomen, or femur injury requiring operative intervention)
  • Pre-existing neurodegenerative disorder, such as Parkinson's disease, Alzheimer's disease, Huntington's disease, multiple sclerosis, amyotrophic lateral sclerosis
  • Pre-existing thromboembolic disease or coagulopathy, such as hemophilia, von Willebrand disease
  • Presence of systemic disease that might interfere with patient safety, compliance or evaluation of the condition under study (e.g., clinically significant cardiac disease, HIV, Hep B or C) HTLV-1
  • Pre-existing inflammatory or autoimmune disorder (e.g. rheumatoid arthritis, systemic lupus, psoriasis, or ankylosing spondylitis
  • Any other medical condition that in the investigator's opinion would render the protocol procedures dangerous or impair the ability of the patient to receive protocol therapy
  • Female patients who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, 94110, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

RECRUITING

University Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Halifax Infirmary - QEII

Halifax, Nova Scotia, B3K 4N1, Canada

RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Hopital Du Sacre-Coeur de Montreal

Montreal, Quebec, H4J1C5, Canada

RECRUITING

MeSH Terms

Conditions

Spinal Cord InjuriesSpinal Fractures

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesSpinal InjuriesBack InjuriesFractures, Bone

Study Officials

  • Brian Kwon, MD, PhD

    University of British Columbia, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Allan Aludino

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 9, 2019

First Posted

April 11, 2019

Study Start

August 31, 2019

Primary Completion

March 1, 2025

Study Completion

December 1, 2025

Last Updated

July 3, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(4)CA(4)