Normal Saline Infusion After Intravenous Thrombolysis in Stroke (NCT07497542) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Normal Saline Infusion After Intravenous Thrombolysis in Stroke
China752 participantsStarted 2026-04
Plain-language summary
The intravenous administration of abundant normal saline is an easy-to-use strategy commonly employed to expand the blood volume. This study aimed to evaluate the efficacy and safety of the early administration of an abundant normal saline infusion after intravenous thrombolysis for promoting functional independence in patients with acute ischemic stroke. This multicenter, randomized, phase III clinical trial intends to enroll stroke participants who have undergone intravenous thrombolysis. Eligible patients are randomized to receive either abundant intravenous normal saline infusion (2,000-2,500 mL; normal saline group) or a small volume of intravenous normal saline infusion (≤600 mL; control group) immediately after thrombolysis. The primary outcome is the comparison of the ordinal modified Rankin Scale score at 90 days (±3) after randomization between the treatment groups.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18 to 80 years.
. Acute ischemic stroke treated with intravenous thrombolysis.
. Prestroke mordified Rankin Scale score ≤1;
. Admission NIHSS score 4-25, with NIHSS 4-5 requiring the presence of a disabling deficit as defined in the 2026 AHA/ASA Guideline for the Early Management of Patients With Acute Ischemic Stroke.
. Onset-to-needle time≤4.5 hours or DWI-FLAIR mismatch (guided by MRI evaluation) for patients with uncertain stroke onset time according to the inclusion criteria of the WAKE-UP study.
. Signed informed consent.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The modified Rankin Scale distribution
Timeframe: 90 days (±3)
Trial details
NCT IDNCT07497542
SponsorTianjin Medical University General Hospital
. Planned endovascular treatment prior to enrollment.
. History of heart failure, or pre-enrollment brain natriuretic peptide (BNP) ≥100 pg/mL, or clinical presentations or signs suggestive of heart failure.
. History of atrial fibrillation, or pre-enrollment electrocardiogram indicating atrial fibrillation.
. History of valvular heart disease or valve replacement surgery, suggesting cardioembolic stroke.
. History of renal dysfunction, or pre-enrollment serum creatinine \>133 μmol/L, or estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m².
. Severe hemorrhage prior to enrollment, including symptomatic intracranial hemorrhage, gastrointestinal bleeding, respiratory tract bleeding, or massive skin and mucous membrane bleeding.
. Premature termination of intravenous thrombolysis due to any reason, such as hemorrhage, allergic reaction, or seizure.