Treatment of Post-SCI Hypotension (NCT02919917) | Clinical Trial Compass
CompletedPhase 2/3
Treatment of Post-SCI Hypotension
United States66 participantsStarted 2017-06-01
Plain-language summary
While treatment strategies for OH have been identified for use in persons with acute SCI, the field of SCI medicine lacks a gold standard for treatment thresholds and well-defined outcome parameters. Comprehensively documenting the impact of orthostatic hypotension (OH), regardless of symptoms, during acute rehabilitation and identifying the effects of two different treatment approaches on therapy participation and adherence to an intended rehabilitation plan could have a significant impact on clinical practice in the acute rehabilitation setting following SCI.
Who can participate
Age range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Any level of injury;
* Any AIS grade of SCI;
* Non-ventilator dependent
* Primarily wheelchair dependent for mobility;
* Duration of injury \< 1 year
* Systolic BP less than 110 mmHg and/or diastolic BP less than 70 mmHg for males.
* Systolic BP less than 100 mmHg and/or diastolic BP less than 70 mmHg for females
* Primary Language is English.
* Able to provide informed consent
Exclusion Criteria:
* Have insufficient mental capacity to independently provide informed consent
* Have insufficient English speaking or reading ability to provide informed consent or complete assessments in English
* Have contraindications to the use of midodrine hydrochloride
* Are pregnant
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Affected Therapy Sessions
Timeframe: Inpatient hospitalization (up to 4 months)
2
Systolic Blood Pressure
Timeframe: Inpatient hospitalization (up to 4 months)
Trial details
NCT IDNCT02919917
SponsorJames J. Peters Veterans Affairs Medical Center