NO AD: Use of Nitric Oxide (NO) Donors for the Prevention of Autonomic Dysreflexia (AD) During Bowel Care Following SCI

Drug

General health

Online since 16 August 2023, updated 335 days ago

About this trial

This trial is enrolling individuals with chronic spinal cord injury to test the safety and effects of using a short-acting drug (Glyceryl trinitrate) to reduce blood pressure during dangerous blood pressure spikes (autonomic dysreflexia) that can happen during bowel care. If included, participants will receive either: 1) the active drug administered via sublingual spray (0.4 mg) up to three times every 15 minutes; or 2) placebo sublingual spray. Blood pressure testing will be performed during bowel care on two occasions within 28 days, each for up to an hour.

Included participants

Gender

All

Age

19 - 80 years

Injury level

C1 - S5

Severity (AIS)?

Time since injury

≥ 1 year

Injury type

Traumatic

Healthy volunteers

C1-S5

Additionally, participants must

Have known incidence of autonomic dysreflexia.

What’s involved

Type

Drug

Details

- Participants will either receive 1) the active drug administered via sublingual spray (0.4 mg) up to three times every fifteen minutes or 2) placebo sublingual spray. - Blood pressure testing will be performed during bowel care.

Potential benefits

Main benefits

General health

Additional benefits

Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

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