Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
NCT Number: NCT07497542
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Phase 3
Tianjin, Tianjin Municipality, 300052, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The participants will undergo 2,000-2,500 mL normal saline intravenous infusion immediately after intravenous thrombolysis.
Time frame: 90 days (±3)
The ordinal scores on the modified Rankin Scale range from 0 to 6, with higher scores indicating worse outcomes.
Contact information is provided by the study sponsor or research team.
Tianjin Medical University General Hospital
Other
Safety and Efficacy of Immediate Abundant Intravenous Normal Saline Infusion for Stroke After Intravenous Thrombolysis: a Multi-centre Randomized Controlled Phase III Trial
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