ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 33 of 312 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

Mean Arterial Blood Pressure Treatment for Acute Spinal Cord Injury (MAPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02232165
Recruitment Status : Recruiting
First Posted : September 5, 2014
Last Update Posted : November 1, 2017
Sponsor:
Collaborators:
Hotchkiss Brain Institute, University of Calgary
AANS/CNS Section on Disorders of the Spine and Peripheral Nerves
Information provided by (Responsible Party):
Dr W. Bradley Jacobs, University of Calgary

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 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. ASIA sensory score [ Time Frame: 1 year post-injury ]
  2. Proportion of patients achieving a one-grade improvement in ASIA impairment scale (AIS) [ Time Frame: 1 year post-injury ]
  3. Quality of life assessment with Short-Form-36 (SF-36) [ Time Frame: 1 year post-injury ]
  4. Functional outcome assessment with FIM and SCIM [ Time Frame: 1 year post-injury ]

Other Outcome Measures:
  1. Number and severity of adverse events [ Time Frame: Within 1 year of study enrolment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
Contact: W. Bradley Jacobs, MD 403-944-3406 wbjacobs@ucalgary.ca

Locations
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    raley@uthscsa.edu   
Principal Investigator: Mark Muir, MD         
Canada, Alberta
University of Calgary, Foothills Medical Centre Recruiting
Calgary, Alberta, Canada, T2N2T9
Contact: W. Bradley Jacobs, MD    403-944-3406    wbjacobs@ucalgary.ca   
Principal Investigator: W. Bradley Jacobs, MD         
Sub-Investigator: Steven Casha, MD, PhD         
Sub-Investigator: Andreas Kramer, MD         
Sponsors and Collaborators
University of Calgary
Hotchkiss Brain Institute, University of Calgary
AANS/CNS Section on Disorders of the Spine and Peripheral Nerves
Investigators
Principal Investigator: W. Bradley Jacobs, MD University of Calgary

Responsible Party: Dr W. Bradley Jacobs, Assistant Professor, Department of Clinical Neurosciences, University of Calgary
ClinicalTrials.gov Identifier: NCT02232165     History of Changes
Other Study ID Numbers: E-24927
First Posted: September 5, 2014    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017

Keywords provided by Dr W. Bradley Jacobs, University of Calgary:
acute spinal cord injury
hemodynamic therapy
functional outcome

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System