Clinical trial NCT05993078: Normal Saline Infusion for Stroke After Intravenous Thrombolysis
Official title: Safety and Efficacy of Immediate Normal Saline Infusion for Stroke After Intravenous Thrombolysis (NS-STAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain Infarct
Keywords: brian infarction
thrombolysis
haemodilution
normal saline
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
Collaborators: name: Affliated Hospital of Jiujiang University
name: Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
First posted: 2023-08-15
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion criteria

1. AIS;
2. Age 18-80 years;
3. Prestroke mRS≤1;
4. NIHSS score 0-25;
5. Onset-to-needle time≤4.5 h;
6. Sign the informed consent. Exclusion criteria

(1) Massive infarction, characterized by infarction area larger than 1/3 of the effected middle cerebral artery territory and/or the cerebellum territory presented in admitted computed tomography (CT) or MRI; (2) Intention to undergo endovascular treatment; (3) History of heart failure or pre-IVT BNP≥500pg/ml or having presentations or signs indicating heart failure; (4) Haemorrhage during IVT, including ICH, severe digestive haemorrhage and severe respiratory haemorrhage; (5) Allergy to thrombolysis drugs; (6) Intolerant to thrombolysis due to any reasons and had to terminate thrombolysis; (7) Arterial puncture at a non-compressible site within previous 7 days, major surgery within previous 14 days, sever trauma, gastrointestinal or urinary tract bleeding within previous 21 days; (8) Cerebral infarction or myocardial infarction within previous 3 months, previous intracranial haemorrhage (ICH) including parenchymal haemorrhage, intraventricular haemorrhage, subarachnoid haemorrhage, subdural/external haematoma, etc; (9) Severe brain trauma, intracranial or intraspinal surgery within previous 3 months or known malignant intracranial neoplasm, giant intracranial aneurysm or arteriovenous malformation; (10) Persistent systolic blood pressure≥180mmHg or diastolic blood pressure≥100mmHg; (11) Admitted blood glucose\<2.8mmol/L or \>22.22mmol/L; (12) Defect in coagulation, for example, current use of oral warfarin with an international normalised ratio\>1.7, or prothrombin time\>15s, or heparins during the last 48 hours, or use of direct thrombin inhibitors or direct factor Xa inhibitors during the last 48 hours or with an elevated activated partial thromboplastin time; (13) Known defect of platelet or clotting function, platelet count\<100×109/L; (14) Stroke mimics, such as seizure and hysteria; (15) Brain haemorrhage identified by CT or MRI; (16) Any terminal illness such that patients would not be expected to survive\>1 year; (17) Pregnant women or nursing mother; (18) Poor compliance, or inability to adhere to the trial protocol or follow-up; (19) Participating in other clinical trials within previous 3 months.

Primary outcomes:
measure: Number of Participants With 90-day Favorable Outcome
timeFrame: 90 days
Secondary outcomes:
measure: NIHSS Scores at 24 Hours
timeFrame: 24 hours
measure: NIHSS Scores on Day 7
timeFrame: 7 days
measure: mRS on Day 7
timeFrame: 7 days
measure: mRS on Day 30
timeFrame: 30 days
measure: Number of Participants With Barthel Index 60-100 on Day 30
timeFrame: 30 days
measure: Number of Participants With Barthel Index 60-100 on Day 90
timeFrame: 90 days
measure: Number of Pariticipants With Early Neurological Deterioration (END, △NIHSS≥2)
timeFrame: 24 hours
measure: Number of Participants With Early Neurological Deterioration (END, △NIHSS≥4)
timeFrame: 24 hours
measure: Imaging Infarction Volume at 24 Hours
timeFrame: 24 hours
measure: Blood Pressure at 24 Hours
timeFrame: 24 hours
measure: Ejection Fraction
timeFrame: 72 hours
measure: Death Rate
timeFrame: 90 days
measure: Number of Paricipants With Intracaranial Hemorrhage
timeFrame: 7 days
measure: Number of Participants With Symptomatic Intracranial Hemorrhage
timeFrame: 7 days
measure: Neutrophil-to-lymphocyte Ratio (NLR)
timeFrame: 24-48 hours
measure: Platelet-to-lymphocyte (PLR)
timeFrame: 24-48 hours
measure: SII
timeFrame: 24-48 hours
measure: S100-β
timeFrame: 24-48 hours
measure: Myeloperoxidase (MPO)
timeFrame: 24-48 hours
measure: Brain Derived Neurotrophic Factor (BDNF)
timeFrame: 24-48 hours
Other outcomes:
Locations:
city: Cangzhou
country: China
facility: Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province
state: Heibei
city: Jiujiang
country: China
facility: Affiliated Hospital of Jiujiang University
state: Jiangxi
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
References: