NCT07497542

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
752

participants targeted

Target at P75+ for phase_3

Timeline
40mo left

Started Apr 2026

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Sep 2029

First Submitted

Initial submission to the registry

March 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

March 23, 2026

Last Update Submit

April 19, 2026

Conditions

Brain Infarction

Keywords

brain infarctionthrombolysishaemodilutionnormal saline

Outcome Measures

Primary Outcomes (1)

  • The modified Rankin Scale distribution

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

    90 days (±3)

Study Arms (2)

Normal saline group

EXPERIMENTAL
Drug: normal saline

Control group

SHAM COMPARATOR
Drug: normal saline

Interventions

normal salineDRUG

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

Normal saline group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Signed informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

MeSH Terms

Conditions

Brain Infarction

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Jiayue Ding, MD.

CONTACT

+86 18518347837sjnkzz2@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

March 23, 2026

First Posted

March 27, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations

CN(1)