Extra Saline Fluid After Clot-Dissolving Treatment for Ischemic Stroke
Tests extra normal saline fluid after thrombolysis in adults with ischemic stroke.
Plain-language title generated from the registry record
Registry title: Normal Saline Infusion After Intravenous Thrombolysis in Stroke
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with an acute ischemic stroke who have just had clot-dissolving treatment (intravenous thrombolysis). It tests a large versus a small saline drip given right after.
- Age
- 18 to 80 years
- Sex
- All sexes can join
- Disease stage
- Acute ischemic stroke treated with intravenous thrombolysis; before the stroke, modified Rankin Scale score ≤1; on admission NIHSS score 4-25 (for 4-5, a disabling deficit is needed); onset-to-needle time ≤4.5 hours, or an MRI DWI-FLAIR mismatch if the onset time is uncertain
- Earlier treatment
- Must have had intravenous thrombolysis. Must not have planned endovascular treatment before enrolment. Must not have taken part in another clinical trial in the previous 3 months.
Main reasons for not taking part
- Contraindications to intravenous thrombolysis
- History of heart failure, atrial fibrillation, valvular heart disease or valve replacement
- Kidney problems (creatinine >133 μmol/L (1.5 mg/dL) or eGFR <60 mL/min/1.73 m²)
- Severe bleeding before enrolment
- Thrombolysis stopped early for any reason, or unable to follow the trial plan
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07497542, who can take part
Where in China
- Tianjin Medical University General HospitalTianjin, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Tianjin Medical University General Hospital
- Trial code
- NCT07497542
- Record updated
- 23 April 2026
- Original description
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.Read full original descriptionShow less
Safety and Efficacy of Immediate Abundant Intravenous Normal Saline Infusion for Stroke After Intravenous Thrombolysis: a Multi-centre Randomized Controlled Phase III Trial
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.
Inclusion: 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: Planned endovascular treatment prior to enrollment; Severe hemorrhage prior to enrollment, including symptomatic intracranial hemorrhage, gastrointestinal bleeding, respiratory tract bleeding, or massive skin and mucous membrane bleeding; Participation in another clinical trial within the previous 3 months; 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; Premature termination of intravenous thrombolysis due to any reason, such as hemorrhage, allergic reaction, or seizure; History of renal dysfunction, or pre-enrollment serum creatinine >133 μmol/L, or estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m²; Contraindications to intravenous thrombolysis; Poor compliance, or inability to adhere to the trial protocol or complete follow-up.