NCT07497542

Normal Saline Infusion After Intravenous Thrombolysis in Stroke

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 752 (estimated)
• Sponsor: Tianjin Medical University General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Infarction

Interventions

Type	Name	Description
DRUG	normal saline	The participants will undergo 2,000-2,500 mL normal saline intravenous infusion immediately after intravenous thrombolysis.
DRUG	normal saline	The participants will receive ≤600 mL of normal saline infusion after intravenous thrombolysis.

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-08-01
• Completion: 2029-09-01
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: China