Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Rick Hansen Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Objective 1. To determine if actively maintaining an SCPP of at least 65 mmHg with a combination of MAP augmentation and CSF drainage promotes better neurologic recovery than routine hemodynamic management that focuses solely on MAP augmentation.
Objective 2. To determine if actively maintaining an SCPP of at least 65 mmHg with a combination of MAP augmentation and CSF drainage will allow for a reduction in the usage of vasopressors in acute SCI.
Objective 3. To determine the feasibility of draining CSF to reduce ITP in the acute post-injury setting, when the cord may be swollen against the dura causing subarachnoid space occlusion at the injury site.
Objective 4. To determine if there are complications associated with the installation of the intrathecal catheter and drainage of CSF in the acute SCI patient.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCP Pressure Management | Other | Active management of Spinal Cord Perfusion Pressure (SCPP) at or above 65 mmHg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCPP Management => 65 mmHg | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of specific biochemical markers in CSF and Blood | CSF and blood samples will be obtained from the intrathecal catheter at 8-hour intervals, three times daily, for 7 days. These samples will be markers that correlate with injury severity and predict neurological outcome. | 7 days |
| Spinal Cord Perfusion Pressure (SCPP) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Allan Aludino | Contact | 604-875-4111 | 61689 | allan.aludino@vch.ca |
| Name | Affiliation | Role |
|---|---|---|
| Brian Kwon, MD, PhD | University of British Columbia, Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuckerberg San Francisco General Hospital and Trauma Center | Recruiting | San Francisco | California | 94110 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D016103 | Spinal Fractures |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
SCPP will be calculated as the difference between the mean arterial pressure and intrathecal pressure. The MAP and ITP will recorded over 7 days post injury. |
| 7 days |
| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198 | United States |
|
| University of New Mexico Health Sciences Center | Recruiting | Albuquerque | New Mexico | 87131 | United States |
|
| University Pittsburgh Medical Center | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
|
| Vancouver General Hospital | Recruiting | Vancouver | British Columbia | V5Z 1M9 | Canada |
|
| Halifax Infirmary - QEII | Recruiting | Halifax | Nova Scotia | B3K 4N1 | Canada |
|
| St. Michael's Hospital | Recruiting | Toronto | Ontario | M5B 1W8 | Canada |
|
| Hopital Du Sacre-Coeur de Montreal | Recruiting | Montreal | Quebec | H4J1C5 | Canada |
|
| D014947 | Wounds and Injuries |
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D050723 | Fractures, Bone |