Mean Arterial Blood Pressure Treatment for Acute Spinal Cord Injury

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02232165
• Date of registration: 02/09/2014
• Prospective Registration: No
• Primary sponsor: University of Calgary
• Public title: Mean Arterial Blood Pressure Treatment for Acute Spinal Cord Injury MAPS
• Scientific title: Mean Arterial Pressure in Spinal Cord Injury (MAPS): Determination of Non-inferiority of a Mean Arterial Pressure Goal of 65 mmHg Compared to a Mean Arterial Pressure Goal of 85 mmHg in Acute Human Traumatic Spinal Cord Injury.
• Date of first enrolment: February 2013
• Target sample size: 17
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02232165
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Canada, United States

Contacts

• Name: W. Bradley Jacobs, MD
• Affiliation: University of Calgary

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 16 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Acute Spinal Cord Injury

Intervention(s)

Other: Induced hypertension

Other: Hypotension avoidance

Primary Outcome(s)

Change in ASIA motor score from baseline [Time Frame: 1 year post-injury]

Secondary Outcome(s)

Proportion of patients achieving a one-grade improvement in ASIA impairment scale (AIS) [Time Frame: 1 year post-injury]

Functional outcome assessment with FIM and SCIM [Time Frame: 1 year post-injury]

Quality of life assessment with Short-Form-36 (SF-36) [Time Frame: 1 year post-injury]

ASIA sensory score [Time Frame: 1 year post-injury]

Secondary ID(s)

E-24927

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AANS/CNS Section on Disorders of the Spine and Peripheral Nerves

Hotchkiss Brain Institute, University of Calgary