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NCT Number: NCT07497542

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 to 80 years.
  • Acute ischemic stroke treated with intravenous thrombolysis.
  • Prestroke mordified Rankin Scale score ≤1;
  • 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.
  • 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.
  • Signed informed consent.

Exclusion criteria

  • Contraindications to intravenous thrombolysis.
  • Planned endovascular treatment prior to enrollment.
  • History of heart failure, or pre-enrollment brain natriuretic peptide (BNP) ≥100 pg/mL, or clinical presentations or signs suggestive of heart failure.
  • History of atrial fibrillation, or pre-enrollment electrocardiogram indicating atrial fibrillation.
  • History of valvular heart disease or valve replacement surgery, suggesting cardioembolic stroke.
  • History of renal dysfunction, or pre-enrollment serum creatinine >133 μmol/L, or estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m².
  • Severe hemorrhage prior to enrollment, including symptomatic intracranial hemorrhage, gastrointestinal bleeding, respiratory tract bleeding, or massive skin and mucous membrane bleeding.
  • Premature termination of intravenous thrombolysis due to any reason, such as hemorrhage, allergic reaction, or seizure.
  • Participation in another clinical trial within the previous 3 months.
  • Poor compliance, or inability to adhere to the trial protocol or complete follow-up.

Treatment and study plan

normal saline

Drug

The participants will undergo 2,000-2,500 mL normal saline intravenous infusion immediately after intravenous thrombolysis.

Primary outcomes

  1. The modified Rankin Scale distribution

    Time frame: 90 days (±3)

    The ordinal scores on the modified Rankin Scale range from 0 to 6, with higher scores indicating worse outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiayue Ding, MD.

CONTACT

[email protected]

+86 18518347837

Sponsors and collaborators

Lead sponsor

Tianjin Medical University General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 27, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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