Normal Saline Infusion After Intravenous Thrombolysis in Stroke

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.

NCT Number	NCT07497542
Lead Sponsor	Tianjin Medical University General Hospital
Conditions	Brain Infarction
Enrollment	752 participants
Start Date	2026-04
Primary Completion	2029-08 (estimated)
Study Completion	2029-09 (estimated)
Updated on ClinicalTrials.gov	2026-04-23