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Can a simple saltwater drip improve stroke outcomes? new trial aims to find out.

NCT ID NCT07497542

Disease control Sponsor: Tianjin Medical University General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving a large amount of IV saline (about 2-2.5 liters) right after clot-busting treatment helps people recover from a stroke better than giving only a small amount. The trial will enroll 752 adults aged 18-80 who had an ischemic stroke and received thrombolysis. The main goal is to see if the saline infusion leads to better functional independence 90 days later.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 752 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 informed consent. Exclusion Criteria: 1. Contraindications 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 electrocardiogram 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 glomerular filtration rate (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.

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Conditions

The condition(s) this trial relates to.

brain infarction ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain infarction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.