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NCT02232165 · ClinicalTrials.gov registry record · NA
Mean Arterial Blood Pressure Treatment for Acute Spinal Cord Injury
A NA study, sponsored by University of Calgary.
- Terminated
- Registry status
- NA
- Development phase
- 17
- Enrollment target
NCT02232165 is a NA study that was terminated before completion, run by University of Calgary. The registered enrollment target is 17 participants.
The verdict
NCT02232165, a NA study, was terminated before completion, sponsored by University of Calgary.
- TERMINATED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
Study 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
Interventions
- OTHER Hypotension avoidance
- OTHER Induced hypertension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2013-02 |
| Est. Completion | 2019-09-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02232165
The ClinicalTrials.gov registry entry for NCT02232165 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Calgary, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Hypotension avoidance is the first listed.
NCT02232165 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02232165 about?
NCT02232165 is a clinical study titled "Mean Arterial Blood Pressure Treatment for Acute Spinal Cord Injury". 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...
What is the current status of trial NCT02232165?
This trial is currently terminated. It is a NA study. The enrollment target is 17 participants. The study started on 2013-02. Estimated completion is 2019-09-20.
What interventions are being tested in trial NCT02232165?
The interventions under investigation include: Hypotension avoidance (OTHER), Induced hypertension (OTHER).
Who is sponsoring clinical trial NCT02232165?
This trial is sponsored by University of Calgary, which has 11 total clinical trials registered on ClinicalTrials.gov.
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