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Normal Saline Infusion After Intravenous Thrombolysis in Stroke Phase 3 752 Randomized

Not yet recruiting
Clinical Trial NCT07497542 is designed to study Treatment for Brain Infarction. This Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on April 1, 2026 until the study accrues 752 participants. Led by Tianjin Medical University General Hospital, this study is expected to complete by September 1, 2029. The latest data from ClinicalTrials.gov was last updated on March 27, 2026.
Brief 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...Show More
Official Title

Safety and Efficacy of Immediate Abundant Intravenous Normal Saline Infusion for Stroke After Intravenous Thrombolysis: a Multi-centre Randomized Controlled Phase III Trial

Conditions
Brain Infarction
Other Study IDs
  • NS-STROKE-2
NCT ID Number
NCT07497542
Start Date (Actual)
2026-04
Last Update Posted
2026-03-27
Completion Date (Estimated)
2029-09
Enrollment (Estimated)
752
Study Type
Interventional
PHASE
Phase 3
Status
Not yet recruiting
Keywords
brain infarction
thrombolysis
haemodilution
normal saline
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalNormal saline group
normal saline
The participants will undergo 2,000-2,500 mL normal saline intravenous infusion immediately after intravenous thrombolysis.
Sham ComparatorControl group
normal saline
The participants will receive ≤600 mL of normal saline infusion after intravenous thrombolysis.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
The modified Rankin Scale distribution
The ordinal scores on the modified Rankin Scale
90 days (±3)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Age 18 to 80 years.
  2. Acute ischemic stroke treated with intravenous thrombolysis.
  3. Prestroke mordified Rankin Scale score ≤1;
  4. 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.
  5. 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.
  6. Signed informed consent.

  1. Contraindications to intravenous thrombolysis.
  2. Planned endovascular treatment prior to enrollment.
  3. History of heart failure, or pre-enrollment brain natriuretic peptide (BNP) ≥500 pg/mL, or clinical presentations or signs suggestive of heart failure.
  4. History of atrial fibrillation, or pre-enrollment electrocardiogram indicating atrial fibrillation.
  5. History of valvular heart disease or valve replacement surgery, suggesting cardioembolic stroke.
  6. History of renal dysfunction, or pre-enrollment serum creatinine >133 μmol/L, or estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m².
  7. Severe hemorrhage prior to enrollment, including symptomatic intracranial hemorrhage, gastrointestinal bleeding, respiratory tract bleeding, or massive skin and mucous membrane bleeding.
  8. Premature termination of intravenous thrombolysis due to any reason, such as hemorrhage, allergic reaction, or seizure.
  9. Participation in another clinical trial within the previous 3 months.
  10. Poor compliance, or inability to adhere to the trial protocol or complete follow-up.
Tianjin Medical University General Hospital logoTianjin Medical University General Hospital378 active studies to explore
Study Responsible Party
Jiayue Ding, Principal Investigator, MD. PhD., Tianjin Medical University General Hospital
Study Central Contact
Contact: Jiayue Ding, MD., +86 18518347837, [email protected]
1 Study Locations in 1 Countries

Tianjin Municipality

Tianjin Medical University General Hospital, Tianjin, Tianjin Municipality, 300052, China