Status:
COMPLETED
Normal Saline Infusion for Stroke After Intravenous Thrombolysis
Lead Sponsor:
Tianjin Medical University General Hospital
Collaborating Sponsors:
Affliated Hospital of Jiujiang University
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Conditions:
Brain Infarct
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 tri...
Eligibility Criteria
Inclusion
- Inclusion criteria
- AIS;
- Age 18-80 years;
- Prestroke mRS≤1;
- NIHSS score 0-25;
- Onset-to-needle time≤4.5 h;
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2025
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT05993078
Start Date
September 1 2023
End Date
January 8 2025
Last Update
March 12 2025
Active Locations (3)
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1
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province
Cangzhou, Heibei, China, 061014
2
Affiliated Hospital of Jiujiang University
Jiujiang, Jiangxi, China, 332000
3
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052