Brain InfarctionPhase 3NCT07497542
Normal Saline Infusion After Intravenous Thrombolysis in Stroke
A Phase 3 study testing normal saline in people with Brain Infarction, run by Tianjin Medical University General Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Infarction
- What is being tested?
- normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 752 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to Sep 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
About this study
Official title: Safety and Efficacy of Immediate Abundant Intravenous Normal Saline Infusion for Stroke After Intravenous Thrombolysis: a Multi-centre Randomized Controlled Phase III Trial
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.
- Conditions
- Brain Infarction
- Being tested
- normal saline
- Keywords
- brain infarction, thrombolysis, haemodilution, normal saline
- Medical subject headings
- Brain Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal salineDrug
The participants will undergo 2,000-2,500 mL normal saline intravenous infusion immediately after intravenous thrombolysis.
normal salineDrug
The participants will receive ≤600 mL of normal saline infusion after intravenous thrombolysis.
| Study group | Role | What they receive |
|---|---|---|
| Normal saline group | Experimental | Not described Receives: Drug: normal saline |
| Control group | Sham comparator | Not described Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The modified Rankin Scale distribution
The ordinal scores on the modified Rankin Scale range from 0 to 6, with higher scores indicating worse outcomes.
Measured: 90 days (±3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 752 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayue Ding, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497542
- Sponsor's protocol ID
- NS-STROKE-2
- Status last verified
- Apr 2026
- First submitted
- 23 Mar 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Immediate Abundant Intravenous Normal Saline Infusion for Stroke After Intravenous Thrombolysis: a Multi-centre Randomized Controlled Phase III Trial
- ClinicalTrials.gov ID
- NCT07497542
- Acronym / sponsor ID
- NS-STROKE-2
- Conditions
- Brain Infarction
- Keywords
- brain infarction, thrombolysis, haemodilution, normal saline
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 752 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal saline group | Experimental | Drug: normal saline |
| Control group | Sham comparator | Drug: normal saline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normal salineThe participants will undergo 2,000-2,500 mL normal saline intravenous infusion immediately after intravenous thrombolysis. | Drug | Normal saline group |
| normal salineThe participants will receive ≤600 mL of normal saline infusion after intravenous thrombolysis. | Drug | Control group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing normal saline in people with Brain Infarction, run by Tianjin Medical University General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiayue Ding, MD. (+86 18518347837, sjnkzz2@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The modified Rankin Scale distribution (time frame: 90 days (±3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.