This study aims to explore the safety and efficacy of 0.9% normal saline （NS） infusion on stroke after intravenous thrombolysis (IVT), we decided to conduct this multi-centre randomized controlled trial for the first time. This trial will provide an innovative strategy to facilitate functional independence after stroke administered with IVT. This is a multi-center, randomized controlled two arm (1:1 ratio) clinical trial. The enrolled participators will be divided into the NS group and the control group randomly after confirming as acute ischemic stroke (AIS). In the NS group, the patient will undergo NS 2000ml intravenous infusion immediately after IVT, with the speed of 200ml/h. In the control group, the patient will receive an NS 200-400ml after IVT. The primary efficacy is disability at days 90, as scored by means of the modified Rankin scale (mRS), dichotomized as a favorable outcome (a score of 0-2), or an unfavorable outcome (a score of 3 to 6). The secondary outcomes mainly comprise neurological deficits, disability, imaging and laboratory tests at each follow-up time. The safety outcomes include the cerebral edema at 24-hour post-IVT detected by cranial CT, the 24-hour fluctuation of blood pressure and the cardiac function detected by ultrasonic cardiogram within 3 days after IVT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
241
The patient will undergo NS 2000ml intravenous infusion immediately after IVT. Subsequent therapy is based on Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018. All of the subjects should be treated in the hospital at least 7 days according to the guidelines for early management of stroke.
The patients receive an NS 200-400ml after IVT. Subsequent therapy is based on Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018. All of the subjects should be treated in the hospital at least 7 days according to the guidelines for early management of stroke.
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province
Cangzhou, Heibei, China
Affiliated Hospital of Jiujiang University
Jiujiang, Jiangxi, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Number of Participants With 90-day Favorable Outcome
Disability on day 90, as scored by means of the modified Rankin scale (mRS), dichotomized as a favorable outcome (a score of 0 to 2), or an unfavorable outcome (a score of 3 to 6). Scores on mRS range from 0 (no symptoms at all) to 6 (death), with higher values reflecting more severe disability or death.
Time frame: 90 days
NIHSS Scores at 24 Hours
The National Institutes of Health Stroke Scale (NIHSS), a 15-item scale that measures the level of neurologic impairment. Total scores on the NIHSS range from 0 to 42, with higher values reflecting more severe cerebral infarcts (\<5, mild impairment; ≥25, very severe neurologic impairment).
Time frame: 24 hours
NIHSS Scores on Day 7
The National Institutes of Health Stroke Scale (NIHSS), a 15-item scale that measures the level of neurologic impairment. Total scores on the NIHSS range from 0 to 42, with higher values reflecting more severe cerebral infarcts (\<5, mild impairment; ≥25, very severe neurologic impairment).
Time frame: 7 days
mRS on Day 7
Scores on the modified Rankin scale(mRS) range from 0 (no symptoms at all) to 6 (death), with higher values reflecting more severe disability or death.
Time frame: 7 days
mRS on Day 30
Scores on the modified Rankin scale(mRS) range from 0 (no symptoms at all) to 6 (death), with higher values reflecting more severe disability or death.
Time frame: 30 days
Number of Participants With Barthel Index 60-100 on Day 30
The Barthel Index represents functional status at follow-up time, the scores of which range from 0 (complete dependence) to 100 (complete independence) measured by several items, including feeding, bathing, grooming, dressing, bowels, bladder, toilet use, transfers, and stairs.
Time frame: 30 days
Number of Participants With Barthel Index 60-100 on Day 90
The Barthel Index represents functional status at follow-up time, the scores of which range from 0 (complete dependence) to 100 (complete independence) measured by several items, including feeding, bathing, grooming, dressing, bowels, bladder, toilet use, transfers, and stairs.
Time frame: 90 days
Number of Pariticipants With Early Neurological Deterioration (END, △NIHSS≥2)
Early neurological deterioration (END) indicates an increase of ≥2 in the NIHSS score within 24 hours after IVT, and the deterioration is not caused by intracranial hemorrhage that is confirmed by cranial CT. The National Institutes of Health Stroke Scale (NIHSS), a 15-item scale that measures the level of neurologic impairment. Total scores on the NIHSS range from 0 to 42, with higher values reflecting more severe cerebral infarcts.
Time frame: 24 hours
Number of Participants With Early Neurological Deterioration (END, △NIHSS≥4)
Early neurological deterioration (END) indicates an increase of ≥4 in the NIHSS score within 24 hours after IVT, and the deterioration is not caused by intracranial hemorrhage that is confirmed by cranial CT. The National Institutes of Health Stroke Scale (NIHSS), a 15-item scale that measures the level of neurologic impairment. Total scores on the NIHSS range from 0 to 42, with higher values reflecting more severe cerebral infarcts.
Time frame: 24 hours
Imaging Infarction Volume at 24 Hours
Cranial computed tomography (CT) scans are performed before IVT and 24 hours after randomization. The infarction area is confirmed using CT maps and the infarction volume is calculated by 3D-Slicer (Version4.6.2, https://www.slicer.org/).
Time frame: 24 hours
Blood Pressure at 24 Hours
Blood pressure, including systolic blood pressure (SBP) and diastolic blood pressure (DBP), is monitored at 24 hours after randomization.
Time frame: 24 hours
Ejection Fraction
Ejection fraction was assessed by ultrasonic cardiogram within 72 hours after randomization.
Time frame: 72 hours
Death Rate
Death rate within 90 days after randomization.
Time frame: 90 days
Number of Paricipants With Intracaranial Hemorrhage
Intracaranial hemorrhage confirmed by cranial CT within 7 days after randomization.
Time frame: 7 days
Number of Participants With Symptomatic Intracranial Hemorrhage
Symptomatic intracranial hemorrhage indicates NIHSS deterioration≥2 scores in combination with intracranial hemorrhage on CT scan without other causes for the deterioration within 7 days after randomization.
Time frame: 7 days
Neutrophil-to-lymphocyte Ratio (NLR)
Peripheral blood inflammatory indices, neutrophil-to-lymphocyte ratio (NLR),24-48 hours after randomization.
Time frame: 24-48 hours
Platelet-to-lymphocyte (PLR)
Peripheral blood inflammatory indices, platelet-to-lymphocyte (PLR) at 24-48 hours after randomization.
Time frame: 24-48 hours
SII
Peripheral blood inflammatory indices, (platelet✖neurophil)/lymphocyte (SII) at 24-48 hours after randomization.
Time frame: 24-48 hours
S100-β
Laboratory examinations, peripehral S100-β at 24-48 hours after randomization.
Time frame: 24-48 hours
Myeloperoxidase (MPO)
Laboratory examinations, peripheral myeloperoxidase (MPO) at 24-48 hours after randomization.
Time frame: 24-48 hours
Brain Derived Neurotrophic Factor (BDNF)
Laboratory examinations, brain derived neurotrophic factor (BDNF)at 24-48 hours after randomization.
Time frame: 24-48 hours
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