Efficacy of Nitric Oxide in Stroke-2

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2021
INTERVENTION: Patients will be randomized (1:1) to receive either glyceryl trinitrate patches or sham patches. Randomization will be performed by the Nottingham Stroke Trials Unit (STU) and involve computerised stratification by stroke type (IS or not known; ICH) and minimisation on age, severity, time, systolic blood pressure and candidate for or received reperfusion therapy. Patients, relatives, researchers and outcome assessors will be masked to treatment allocation Active: Transdermal glyceryl trinitrate (GTN) 5 mg placed on back or shoulders and applied for 2 days. Comparator: Transdermal Duoderm hydrocolloid dressing placed on back or shoulders and applied for 2 days. Following 2 days of treatment both arms will have the same follow up ‐ follow‐ups will be carried out on Day 2, the day of death or discharge from hospital, day 90 and day 365. CONDITION: Stroke ; Circulatory System ; Stroke, not specified as haemorrhage or infarction PRIMARY OUTCOME: The feasibility of recruiting 120 (100 ischaemic stroke/20 intra‐cerebral haemorrhage) eligible stroke patients who consent to participate in the study within 12 months of the start date SECONDARY OUTCOME: ; 1. Blood pressure measured using standard sphygmomanometer at baseline, Day 0 post treatment, Day 1 during treatment; 2. Disability measured using the National Institutes of Health Stroke Scale (NIHSS) at baseline and Day 2; 3. Feeding and dysphagia measured using the Dysphagia Severity Rating Scale (DSRS) at Day 2; 4. Hospital utilisation (thrombectomy, hemicraniectomy surgery, hyperacute stroke unit, rehabilitation, physiotherapy, occupational therapy, speech and language therapy, ITU use) measured by review of medical notes at death/discharge; 5. Functional ability measured using the modified Rankin scale (mRS) and Barthel index (BI) at Day 90 and Day 365; 6. Cognition measured using the mini mental state examination (MMSE) at Day 90 and Day 365; 7. Mood measured using the Zung Depression Scale (ZDS) at Day 90 and Day 365; 8. Quality of life measured using EurolQuol (EQ5D) at Day 90 and Day 365; INCLUSION CRITERIA: 1. 120 adults (=18 years old) with presentation compatible with stroke) 2. Treatment 3‐5 hours post ictus (or from when last seen free of stroke symptoms) 3. Limb weakness at time of enrolment (NIHSS on affected are and/or leg 1‐4) 4. Systolic blood pressure (=120 mmHg) 5. If a CT/MR scan has already been performed, then it shows acute intracerebral haemorrhage or ischaemic stroke, or is normal 6. Waiver of consent for treatment to ensure GTN given in 3‐5 hour time‐window (and thrombolysis not delayed if ischaemic stroke)
Epistemonikos ID: fe4de6df506540808fe076ebf23d0c295942cb34
First added on: Aug 25, 2024