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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: Clinical Trial NA study, sponsored by University of Calgary.
NCT02232165 is a NA study that was terminated before completion, run by University of Calgary. The registered enrollment target is 17 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
A difference of ≤10 ASIA motor points change from baseline between groups will be considered as non-inferiority.
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 |
Why NCT02232165 stopped before completion
NCT02232165 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Hypotension avoidance is the first listed.
NCT02232165 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02232165's enrollment target sits among peer trials
17 1871st of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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