drugset / Trial / NCT07497542

Normal Saline Infusion After Intravenous Thrombolysis in Stroke

NCT07497542

Phase 3 Not yet recruiting 752 enrolled Tianjin Medical University General Hospital
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2026-04
Primary completion
2029-08
Completion
2029-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator sodium chloride Unknown 600 ml Intravenous
Comparator sodium chloride Unknown 2000 ml Intravenous
Comparator sodium chloride Unknown 2500 ml Intravenous

Indications