Status:
TERMINATED
Mean Arterial Blood Pressure Treatment for Acute Spinal Cord Injury
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Hotchkiss Brain Institute, University of Calgary
AANS/CNS Section on Disorders of the Spine and Peripheral Nerves
Conditions:
Acute Spinal Cord Injury
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
Current guidelines for the clinical management of acute spinal cord injury (SCI) recommend maintenance of mean arterial blood pressure (MAP) at 85 to 90 mmHg for the first seven days after SCI as a cl...
Eligibility Criteria
Inclusion
- Age greater than or equal to 16 years.
- Motor complete or incomplete (ASIA A, B, or C) acute traumatic SCI involving spinal levels between C0 and T12.
- Written and informed consent from patient or a legally acceptable representative.
- Randomization and initiation of management protocol within 24 hours of injury.
- Reasonable expectation of availability to receive the full 7-day course of therapy and be available for follow up evaluations.
Exclusion
- Acute traumatic SCI \> 24 hours old.
- Central cord syndrome, defined as ASIA C or D with mean lower extremity score greater than upper extremity score.
- Isolated sensory deficit, motor intact.
- Isolated radicular motor deficit, defined as a unilateral motor deficit restricted to a single myotome.
- Pregnancy.
- Associated conditions interfering with informed consent or outcome assessment including closed head injury and major orthopedic injuries.
- Polytrauma: Abbreviated Injury Severity Score \>3 in any area other than head.
- Known uncorrected severe coronary artery disease or evidence of active coronary ischemia (ECG changes, positive troponin) will be excluded.
- Advanced cardiac, pulmonary, hepatic or liver disease; the former will be operationally defined using NCI Toxicity Criteria (Grade 2 or higher).
- Allergy or other contraindication to norepinephrine.
- A known diagnosis of cancer (except basal cell cancer).
- Uncontrolled hypertension, defined as blood pressure persistently above 220 mmHg systolic or 120 mmHg diastolic, despite antihypertensive therapy.
- Any patients living in a nursing home or supervised living centre. Patients must be historically fully independent in all activities of daily living including banking, shopping, cooking, toileting, showering and dressing.
- Any other medical condition, in the investigator's opinion, for which the patient should not be included in the trial.
- Pre-existing and active major psychiatric or other chronic neurological disease.
- Patients who have a history of substance abuse or dependency within 12 months prior to the study.
- Currently participating in another interventional investigational study.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2019
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT02232165
Start Date
February 1 2013
End Date
September 20 2019
Last Update
September 25 2019
Active Locations (2)
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1
University of Texas Health Science Center San Antonio
San Antonio, Texas, United States, 78229
2
University of Calgary, Foothills Medical Centre
Calgary, Alberta, Canada, T2N2T9