Mean Arterial Blood Pressure Treatment for Acute Spinal Cord Injury (MAPS)
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|ClinicalTrials.gov Identifier: NCT02232165|
Recruitment Status : Recruiting
First Posted : September 5, 2014
Last Update Posted : November 1, 2017
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 clinical option. Unfortunately, the medical evidence to support this recommendation exists only at the clinical case series level (Class III data). Furthermore, maintenance of sustained systemic hypertension, as per clinical guidelines, may be associated with risks to the patient via adverse medical events. Given this equivocal evidence, the investigators group has questioned the merit of sustained induced hypertension following acute SCI and has previously conducted a randomized, prospective controlled feasibility study to further examine this issue. This prior pilot study randomized patients with acute SCI to a spinal cord perfusion pressure (SCPP = MAP - intrathecal pressure (ITP)) target of ≥ 75 mmHg or to a control group (hypotension avoidance, MAP ≥ 65 mmHg). The primary endpoint measure was defined as the change in American Spinal Injury Association (ASIA) motor score from baseline. No difference in the primary outcome was noted at one-year post-SCI in this study.
In light of this pilot data, the investigators hypothesize that maintenance of normotension (MAP ≥ 65mmHg) is not inferior to induced hypertension (MAP ≥ 85mmHg) for 7 days following acute SCI. As such, the investigators propose to conduct a Phase III non-inferiority prospective, randomized clinical trial in acute SCI patients. Subjects will be randomized into one of two MAP management groups for 7 days; Group 1 will be managed with a target MAP ≥ 65 mmHg, while Group 2 will be managed with a target MAP ≥ 85 mmHg. The primary endpoint will be change in ASIA motor score from baseline at 12 months post injury. A difference of ≤10 ASIA motor points change from baseline between groups will be considered as non-inferiority. Secondary endpoints will include ASIA sensory score, proportion of patients achieving a one grade improvement in ASIA impairment scale, quality of life assessment (as measured by Short-Form-36 [SF-36]) and functional outcome (as measured by the Spinal Cord Independence Measure (SCIM) and Functional Independence Measure (FIM). These will be measured at baseline, 72 hours and 3, 6 and 12 months from injury. Adverse events will be meticulously recorded. The information gleaned from this trial will provide valuable information for the acute treatment of traumatic SCI and will serve the objective of optimizing current clinical practice and thus maximizing medical and neurological outcome for individuals following acute traumatic SCI.
|Condition or disease||Intervention/treatment||Phase|
|Acute Spinal Cord Injury||Other: Hypotension avoidance Other: Induced hypertension||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official 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.|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: Hypotension avoidance (MAP >= 65 mmHg)
Mean arterial blood pressure is maintained >= 65 mmHg for 7 days following acute SCI.
Other: Hypotension avoidance
Induced hypertension with MAP >= 85 mmHg for 7 days following SCI is the current recommended clinical option guideline. Our intervention tests whether hypotension avoidance and maintenance of MAP >= 65 mmHg is not inferior to induced hypertension.
Active Comparator: Induced hypertension (MAP >= 85 mmHg)
Induced hypertension with mean arterial blood pressure >= 85 mmHg for 7 days following acute SCI.
Other: Induced hypertension
Induced hypertension with MAP >= 85 mmHg for 7 days following SCI is the current recommended clinical option guideline.
- Change in ASIA motor score from baseline [ Time Frame: 1 year post-injury ]A difference of ≤10 ASIA motor points change from baseline between groups will be considered as non-inferiority.
- ASIA sensory score [ Time Frame: 1 year post-injury ]
- Proportion of patients achieving a one-grade improvement in ASIA impairment scale (AIS) [ Time Frame: 1 year post-injury ]
- Quality of life assessment with Short-Form-36 (SF-36) [ Time Frame: 1 year post-injury ]
- Functional outcome assessment with FIM and SCIM [ Time Frame: 1 year post-injury ]
- Number and severity of adverse events [ Time Frame: Within 1 year of study enrolment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232165
|Contact: W. Bradley Jacobs, MDfirstname.lastname@example.org|
|United States, Texas|
|University of Texas Health Science Center San Antonio||Recruiting|
|San Antonio, Texas, United States, 78229|
|Contact: Jessica Raley, PhD 210-743-4148 email@example.com|
|Principal Investigator: Mark Muir, MD|
|University of Calgary, Foothills Medical Centre||Recruiting|
|Calgary, Alberta, Canada, T2N2T9|
|Contact: W. Bradley Jacobs, MD 403-944-3406 firstname.lastname@example.org|
|Principal Investigator: W. Bradley Jacobs, MD|
|Sub-Investigator: Steven Casha, MD, PhD|
|Sub-Investigator: Andreas Kramer, MD|
|Principal Investigator:||W. Bradley Jacobs, MD||University of Calgary|