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Not yet recruitingNCT07497542Updated Apr 23, 2026

Normal Saline Infusion After Intravenous Thrombolysis in Stroke

A Phase 3 interventional study of normal saline and normal saline in Brain Infarction, sponsored by Tianjin Medical University General Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Tianjin Medical University General Hospital · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
752
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Brain Infarction

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Keywords

  • brain infarction
  • thrombolysis
  • haemodilution
  • normal saline
03

In context

Brain Infarction

93 studies on the registry are indexed under Brain Infarction; 19 are open to participants now.

This study's planned enrollment of 752 is above the median of 134 across 67 interventional studies indexed under Brain Infarction.

Browse Brain Infarction studies →

Lead sponsor

Tianjin Medical University General Hospital is the lead sponsor of 75 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18 to 80 years.
  2. Acute ischemic stroke treated with intravenous thrombolysis.
  3. Prestroke mordified Rankin Scale score ≤1;
  4. 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.
  5. 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.
  6. Signed .

Exclusion criteria

Exclusion Criteria:

  1. to intravenous thrombolysis.
  2. Planned endovascular treatment prior to enrollment.
  3. History of heart failure, or pre-enrollment brain natriuretic peptide (BNP) ≥100 pg/mL, or clinical presentations or signs suggestive of heart failure.
  4. History of atrial fibrillation, or pre-enrollment indicating atrial fibrillation.
  5. History of valvular heart disease or valve replacement surgery, suggesting cardioembolic stroke.
  6. History of renal dysfunction, or pre-enrollment serum creatinine >133 μmol/L, or estimated (eGFR) \<60 mL/min/1.73 m².
  7. Severe hemorrhage prior to enrollment, including symptomatic intracranial hemorrhage, gastrointestinal bleeding, respiratory tract bleeding, or massive skin and mucous membrane bleeding.
  8. Premature termination of intravenous thrombolysis due to any reason, such as hemorrhage, allergic reaction, or seizure.
  9. Participation in another clinical trial within the previous 3 months.
  10. Poor compliance, or inability to adhere to the trial protocol or complete follow-up.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
752 participants (estimated)

Study arms

  • Experimental
    Normal saline group

    Drug: normal saline

  • Sham comparator
    Control group

    Drug: normal saline

Interventions

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

  • The participants will receive ≤600 mL of normal saline infusion after intravenous thrombolysis.

06

What researchers measure

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.

    Time frame: 90 days (±3)

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2026; primary completion for Aug 2029, 40 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 23, 2026
First posted
Mar 27, 2026
StartEst.
Apr 2026
Primary completionEst.
Aug 2029
CompletionEst.
Sep 2029
Last update
Apr 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07497542
Lead sponsor
Tianjin Medical University General Hospital
Responsible party
Jiayue Ding (Principle investigator, Tianjin Medical University General Hospital) — Principal investigator
First posted
Mar 27, 2026
Start date
Apr 2026 (estimated)
Primary completion
Aug 2029 (estimated)
Completion
Sep 2029 (estimated)
Last update
Apr 23, 2026

Study contacts

Jiayue Ding, MD.
Contact
sjnkzz2@163.com
+86 18518347837

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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