Brain InfarctPhase 2NS-STARNCT05993078

Normal Saline Infusion for Stroke After Intravenous Thrombolysis

A Phase 2 study testing 0.9% NaCl 2000ml and 0.9% NaCl 200-400ml in people with Brain Infarct, run by Tianjin Medical University General Hospital at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Brain Infarct
What is being tested?: 0.9% NaCl 2000ml and 0.9% NaCl 200-400ml
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 241 participants
Where: 3 sitesChina
Study dates: 1 Sep 2023to 8 Jan 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

AIS;
Age 18-80 years;
Prestroke mRS≤1;
NIHSS score 0-25;
Onset-to-needle time≤4.5 h;
Sign the informed consent. Exclusion criteria
Massive infarction, characterized by infarction area larger than 1/3 of the effected middle cerebral artery territory and/or the cerebellum territory presented in admitted computed tomography (CT) or MRI; (2) Intention to undergo endovascular treatment; (3) History of heart failure or pre-IVT BNP≥500pg/ml or having presentations or signs indicating heart failure; (4) Haemorrhage during IVT, including ICH, severe digestive haemorrhage and severe respiratory haemorrhage; (5) Allergy to thrombolysis drugs; (6) Intolerant to thrombolysis due to any reasons and had to terminate thrombolysis; (7) Arterial puncture at a non-compressible site within previous 7 days, major surgery within previous 14 days, sever trauma, gastrointestinal or urinary tract bleeding within previous 21 days; (8) Cerebral infarction or myocardial infarction within previous 3 months, previous intracranial haemorrhage (ICH) including parenchymal haemorrhage, intraventricular haemorrhage, subarachnoid haemorrhage, subdural/external haematoma, etc; (9) Severe brain trauma, intracranial or intraspinal surgery within previous 3 months or known malignant intracranial neoplasm, giant intracranial aneurysm or arteriovenous malformation; (10) Persistent systolic blood pressure≥180mmHg or diastolic blood pressure≥100mmHg; (11) Admitted blood glucose<2.8mmol/L or >22.22mmol/L; (12) Defect in coagulation, for example, current use of oral warfarin with an international normalised ratio>1.7, or prothrombin time>15s, or heparins during the last 48 hours, or use of direct thrombin inhibitors or direct factor Xa inhibitors during the last 48 hours or with an elevated activated partial thromboplastin time; (13) Known defect of platelet or clotting function, platelet count<100×109/L; (14) Stroke mimics, such as seizure and hysteria; (15) Brain haemorrhage identified by CT or MRI; (16) Any terminal illness such that patients would not be expected to survive>1 year; (17) Pregnant women or nursing mother; (18) Poor compliance, or inability to adhere to the trial protocol or follow-up; (19) Participating in other clinical trials within previous 3 months.

Who cannot join

None listed.

Trial locations and contacts

3 sites in 1 country.

China3 sites

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province
Cangzhou, Heibei, 061014
Affiliated Hospital of Jiujiang University
Jiujiang, Jiangxi, 332000
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052

Other trials in China

About this study

Official title: Safety and Efficacy of Immediate Normal Saline Infusion for Stroke After Intravenous Thrombolysis (NS-STAR)

This study aims to explore the safety and efficacy of 0.9% normal saline （NS） infusion on stroke after intravenous thrombolysis (IVT), we decided to conduct this multi-centre randomized controlled trial for the first time. This trial will provide an innovative strategy to facilitate functional independence after stroke administered with IVT. This is a multi-center, randomized controlled two arm (1:1 ratio) clinical trial. The enrolled participators will be divided into the NS group and the control group randomly after confirming as acute ischemic stroke (AIS). In the NS group, the patient will undergo NS 2000ml intravenous infusion immediately after IVT, with the speed of 200ml/h. In the control group, the patient will receive an NS 200-400ml after IVT. The primary efficacy is disability at days 90, as scored by means of the modified Rankin scale (mRS), dichotomized as a favorable outcome (a score of 0-2), or an unfavorable outcome (a score of 3 to 6). The secondary outcomes mainly comprise neurological deficits, disability, imaging and laboratory tests at each follow-up time. The safety outcomes include the cerebral edema at 24-hour post-IVT detected by cranial CT, the 24-hour fluctuation of blood pressure and the cardiac function detected by ultrasonic cardiogram within 3 days after IVT.

Conditions: Brain Infarct
Being tested: 0.9% NaCl 2000ml, 0.9% NaCl 200-400ml
Keywords: brian 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.

0.9% NaCl 2000mlDrug
The patient will undergo NS 2000ml intravenous infusion immediately after IVT. Subsequent therapy is based on Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018. All of the subjects should be treated in the hospital at least 7 days according to the guidelines for early management of stroke.
0.9% NaCl 200-400mlDrug
The patients receive an NS 200-400ml after IVT. Subsequent therapy is based on Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018. All of the subjects should be treated in the hospital at least 7 days according to the guidelines for early management of stroke.

Study groups in NCT05993078
Study group	Role	What they receive
NS group	Experimental	The patient will undergo NS 2000ml intravenous infusion immediately after IVT. Receives: Drug: 0.9% NaCl 2000ml
Control group	Placebo comparator	The patient will the patients receive an NS 200-400ml after IVT. Receives: Drug: 0.9% NaCl 200-400ml

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With 90-day Favorable Outcome
Disability on day 90, as scored by means of the modified Rankin scale (mRS), dichotomized as a favorable outcome (a score of 0 to 2), or an unfavorable outcome (a score of 3 to 6). Scores on mRS range from 0 (no symptoms at all) to 6 (death), with higher values reflecting more severe disability or death.
Measured: 90 days

Secondary outcomes (20)

NIHSS Scores at 24 Hours
The National Institutes of Health Stroke Scale (NIHSS), a 15-item scale that measures the level of neurologic impairment. Total scores on the NIHSS range from 0 to 42, with higher values reflecting more severe cerebral infarcts (<5, mild impairment; ≥25, very severe neurologic impairment).
Measured: 24 hours
NIHSS Scores on Day 7
The National Institutes of Health Stroke Scale (NIHSS), a 15-item scale that measures the level of neurologic impairment. Total scores on the NIHSS range from 0 to 42, with higher values reflecting more severe cerebral infarcts (<5, mild impairment; ≥25, very severe neurologic impairment).
Measured: 7 days
mRS on Day 7
Scores on the modified Rankin scale(mRS) range from 0 (no symptoms at all) to 6 (death), with higher values reflecting more severe disability or death.
Measured: 7 days
mRS on Day 30
Scores on the modified Rankin scale(mRS) range from 0 (no symptoms at all) to 6 (death), with higher values reflecting more severe disability or death.
Measured: 30 days
Number of Participants With Barthel Index 60-100 on Day 30
The Barthel Index represents functional status at follow-up time, the scores of which range from 0 (complete dependence) to 100 (complete independence) measured by several items, including feeding, bathing, grooming, dressing, bowels, bladder, toilet use, transfers, and stairs.
Measured: 30 days
Number of Participants With Barthel Index 60-100 on Day 90
The Barthel Index represents functional status at follow-up time, the scores of which range from 0 (complete dependence) to 100 (complete independence) measured by several items, including feeding, bathing, grooming, dressing, bowels, bladder, toilet use, transfers, and stairs.
Measured: 90 days
Number of Pariticipants With Early Neurological Deterioration (END, △NIHSS≥2)
Early neurological deterioration (END) indicates an increase of ≥2 in the NIHSS score within 24 hours after IVT, and the deterioration is not caused by intracranial hemorrhage that is confirmed by cranial CT. The National Institutes of Health Stroke Scale (NIHSS), a 15-item scale that measures the level of neurologic impairment. Total scores on the NIHSS range from 0 to 42, with higher values reflecting more severe cerebral infarcts.
Measured: 24 hours
Number of Participants With Early Neurological Deterioration (END, △NIHSS≥4)
Early neurological deterioration (END) indicates an increase of ≥4 in the NIHSS score within 24 hours after IVT, and the deterioration is not caused by intracranial hemorrhage that is confirmed by cranial CT. The National Institutes of Health Stroke Scale (NIHSS), a 15-item scale that measures the level of neurologic impairment. Total scores on the NIHSS range from 0 to 42, with higher values reflecting more severe cerebral infarcts.
Measured: 24 hours
Imaging Infarction Volume at 24 Hours
Cranial computed tomography (CT) scans are performed before IVT and 24 hours after randomization. The infarction area is confirmed using CT maps and the infarction volume is calculated by 3D-Slicer (Version4.6.2, https://www.slicer.org/).
Measured: 24 hours
Blood Pressure at 24 Hours
Blood pressure, including systolic blood pressure (SBP) and diastolic blood pressure (DBP), is monitored at 24 hours after randomization.
Measured: 24 hours
Ejection Fraction
Ejection fraction was assessed by ultrasonic cardiogram within 72 hours after randomization.
Measured: 72 hours
Death Rate
Death rate within 90 days after randomization.
Measured: 90 days
Number of Paricipants With Intracaranial Hemorrhage
Intracaranial hemorrhage confirmed by cranial CT within 7 days after randomization.
Measured: 7 days
Number of Participants With Symptomatic Intracranial Hemorrhage
Symptomatic intracranial hemorrhage indicates NIHSS deterioration≥2 scores in combination with intracranial hemorrhage on CT scan without other causes for the deterioration within 7 days after randomization.
Measured: 7 days
Neutrophil-to-lymphocyte Ratio (NLR)
Peripheral blood inflammatory indices, neutrophil-to-lymphocyte ratio (NLR),24-48 hours after randomization.
Measured: 24-48 hours
Platelet-to-lymphocyte (PLR)
Peripheral blood inflammatory indices, platelet-to-lymphocyte (PLR) at 24-48 hours after randomization.
Measured: 24-48 hours
SII
Peripheral blood inflammatory indices, (platelet✖neurophil)/lymphocyte (SII) at 24-48 hours after randomization.
Measured: 24-48 hours
S100-β
Laboratory examinations, peripehral S100-β at 24-48 hours after randomization.
Measured: 24-48 hours
Myeloperoxidase (MPO)
Laboratory examinations, peripheral myeloperoxidase (MPO) at 24-48 hours after randomization.
Measured: 24-48 hours
Brain Derived Neurotrophic Factor (BDNF)
Laboratory examinations, brain derived neurotrophic factor (BDNF)at 24-48 hours after randomization.
Measured: 24-48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20238 Jan 2025

First posted15 Aug 2023
Study start1 Sep 2023
Primary completion20 Dec 2024
Study completion8 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Brain InfarctStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 241 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05993078
Sponsor's protocol ID: NS-STAR
Acronym: NS-STAR
Status last verified: Mar 2025
First submitted: 3 Aug 2023
Last updated: 12 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: We will share study protocol and statistical analysis plan with other researchers.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Brain Infarct trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Immediate Normal Saline Infusion for Stroke After Intravenous Thrombolysis (NS-STAR)
ClinicalTrials.gov ID: NCT05993078
Acronym / sponsor ID: NS-STAR / NS-STAR
Conditions: Brain Infarct
Keywords: brian infarction, thrombolysis, haemodilution, normal saline
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 241 participants (actual)
Lead sponsor: Tianjin Medical University General HospitalUniversity, hospital or other
Collaborators: Affliated Hospital of Jiujiang University, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Study start: 1 Sep 2023 (actual)
Primary completion: 20 Dec 2024 (actual)
Study completion: 8 Jan 2025 (actual)
First posted: 15 Aug 2023 (actual)
Results: Posted 12 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
NS group	Experimental	Drug: 0.9% NaCl 2000mlThe patient will undergo NS 2000ml intravenous infusion immediately after IVT.
Control group	Placebo comparator	Drug: 0.9% NaCl 200-400mlThe patient will the patients receive an NS 200-400ml after IVT.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

AIS;
Age 18-80 years;
Prestroke mRS≤1;
NIHSS score 0-25;
Onset-to-needle time≤4.5 h;

Key exclusion criteria (0 listed)

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
0.9% NaCl 2000mlThe patient will undergo NS 2000ml intravenous infusion immediately after IVT. Subsequent therapy is based on Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018. All of the subjects should be treated in the hospital at least 7 days according to the guidelines for early management of stroke.	Drug	NS group
0.9% NaCl 200-400mlThe patients receive an NS 200-400ml after IVT. Subsequent therapy is based on Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018. All of the subjects should be treated in the hospital at least 7 days according to the guidelines for early management of stroke.	Drug	Control group

Primary outcome

Number of Participants With 90-day Favorable Outcome
Time frame: 90 days
Disability on day 90, as scored by means of the modified Rankin scale (mRS), dichotomized as a favorable outcome (a score of 0 to 2), or an unfavorable outcome (a score of 3 to 6). Scores on mRS range from 0 (no symptoms at all) to 6 (death), with higher values reflecting more severe disability or death.

20 secondary outcomes

NIHSS Scores at 24 Hours
Time frame: 24 hours
NIHSS Scores on Day 7
Time frame: 7 days
mRS on Day 7
Time frame: 7 days
mRS on Day 30
Time frame: 30 days
Number of Participants With Barthel Index 60-100 on Day 30
Time frame: 30 days
Number of Participants With Barthel Index 60-100 on Day 90
Time frame: 90 days
Number of Pariticipants With Early Neurological Deterioration (END, △NIHSS≥2)
Time frame: 24 hours
Number of Participants With Early Neurological Deterioration (END, △NIHSS≥4)
Time frame: 24 hours
Imaging Infarction Volume at 24 Hours
Time frame: 24 hours
Blood Pressure at 24 Hours
Time frame: 24 hours
Ejection Fraction
Time frame: 72 hours
Death Rate
Time frame: 90 days
Number of Paricipants With Intracaranial Hemorrhage
Time frame: 7 days
Number of Participants With Symptomatic Intracranial Hemorrhage
Time frame: 7 days
Neutrophil-to-lymphocyte Ratio (NLR)
Time frame: 24-48 hours
Platelet-to-lymphocyte (PLR)
Time frame: 24-48 hours
SII
Time frame: 24-48 hours
S100-β
Time frame: 24-48 hours
Myeloperoxidase (MPO)
Time frame: 24-48 hours
Brain Derived Neurotrophic Factor (BDNF)
Time frame: 24-48 hours

Results and safety

Results posted to the registry on 12 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NS Group	121	121
Control Group	120	120

Primary outcome: Number of Participants With 90-day Favorable Outcome

Time frame: 90 days. Count of participants. Unit: Participants

Measure	NS Group n = 120	Control Group n = 119
Value	106	93

Population analysed: One patient in each group was lost to follow-up at 90 days.

20 secondary outcomes are reported in the full results.

Adverse events

Time frame: through 90 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NS Group	0 of 121 (0%)	0 of 121 (0%)	2 of 121
Control Group	0 of 120 (0%)	0 of 120 (0%)	5 of 120

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. We will share study protocol and statistical analysis plan with other researchers.

Related trials for Brain Infarct

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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Recruiting
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 0.9% NaCl 2000ml and 0.9% NaCl 200-400ml in people with Brain Infarct, run by Tianjin Medical University General Hospital at 3 sites 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 7 inclusion and 0 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: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With 90-day Favorable Outcome (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05993078.

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 12 Mar 2025.