A Phase 2 interventional study of 0.9% NaCl 2000ml and 0.9% NaCl 200-400ml in Brain Infarct, sponsored by Tianjin Medical University General Hospital. Completed at 3 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by Tianjin Medical University General Hospital · Phase 2, Interventional, and Treatment
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.
93 studies on the registry are indexed under Brain Infarction; 19 are open to participants now.
This study's enrollment of 241 is above the median of 134 across 67 interventional studies indexed under Brain Infarction.
Browse Brain Infarction studies →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.
Inclusion criteria
(1) 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 >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 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.
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.
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.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patient will undergo NS 2000ml intravenous infusion immediately after IVT.
Drug: 0.9% NaCl 2000ml
The patient will the patients receive an NS 200-400ml after IVT.
Drug: 0.9% NaCl 200-400ml
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.
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.
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.
Time frame: 90 days
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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/).
Time frame: 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.
Time frame: 24 hours
Ejection Fraction
Ejection fraction was assessed by ultrasonic cardiogram within 72 hours after randomization.
Time frame: 72 hours
Death Rate
Death rate within 90 days after randomization.
Time frame: 90 days
Number of Paricipants With Intracaranial Hemorrhage
Intracaranial hemorrhage confirmed by cranial CT within 7 days after randomization.
Time frame: 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.
Time frame: 7 days
Neutrophil-to-lymphocyte Ratio (NLR)
Peripheral blood inflammatory indices, neutrophil-to-lymphocyte ratio (NLR),24-48 hours after randomization.
Time frame: 24-48 hours
Platelet-to-lymphocyte (PLR)
Peripheral blood inflammatory indices, platelet-to-lymphocyte (PLR) at 24-48 hours after randomization.
Time frame: 24-48 hours
SII
Peripheral blood inflammatory indices, (platelet✖neurophil)/lymphocyte (SII) at 24-48 hours after randomization.
Time frame: 24-48 hours
S100-β
Laboratory examinations, peripehral S100-β at 24-48 hours after randomization.
Time frame: 24-48 hours
Myeloperoxidase (MPO)
Laboratory examinations, peripheral myeloperoxidase (MPO) at 24-48 hours after randomization.
Time frame: 24-48 hours
Brain Derived Neurotrophic Factor (BDNF)
Laboratory examinations, brain derived neurotrophic factor (BDNF)at 24-48 hours after randomization.
Time frame: 24-48 hours
| Milestone | NS Group | Control Group |
|---|---|---|
| Started | 121 | 120 |
| Completed | 121 | 120 |
| Not completed | 0 | 0 |
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.
| Participants | NS Group | Control Group |
|---|---|---|
| Number of Participants With 90-day Favorable Outcome | 106 | 93 |
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).
| score on a scale | NS Group | Control Group |
|---|---|---|
| NIHSS Scores at 24 Hours | 2 (0 to 4) | 2 (1 to 5) |
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).
| score on scale | NS Group | Control Group |
|---|---|---|
| NIHSS Scores on Day 7 | 1 (0 to 3) | 1 (0 to 3) |
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.
| score on scale | NS Group | Control Group |
|---|---|---|
| mRS on Day 7 | 1 (0 to 2) | 1 (1 to 3) |
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.
| score on a scale | NS Group | Control Group |
|---|---|---|
| mRS on Day 30 | 1 (0 to 2) | 1 (0 to 2) |
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.
| Participants | NS Group | Control Group |
|---|---|---|
| Number of Participants With Barthel Index 60-100 on Day 30 | 108 | 104 |
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.
| Participants | NS Group | Control Group |
|---|---|---|
| Number of Participants With Barthel Index 60-100 on Day 90 | 111 | 105 |
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.
| Participants | NS Group | Control Group |
|---|---|---|
| Number of Pariticipants With Early Neurological Deterioration (END, △NIHSS≥2) | 10 | 25 |
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.
| Participants | NS Group | Control Group |
|---|---|---|
| Number of Participants With Early Neurological Deterioration (END, △NIHSS≥4) | 8 | 19 |
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/).
| ml | NS Group | Control Group |
|---|---|---|
| Imaging Infarction Volume at 24 Hours | 0.21 (0 to 2.52) | 0.31 (0 to 1.82) |
Blood pressure, including systolic blood pressure (SBP) and diastolic blood pressure (DBP), is monitored at 24 hours after randomization.
| mmHg | NS Group | Control Group |
|---|---|---|
| systolic pressure | 142 (133 to 158) | 135 (123 to 148) |
| diastolic pressure | 79 (72 to 87) | 77 (71 to 83) |
Ejection fraction was assessed by ultrasonic cardiogram within 72 hours after randomization.
| percentage | NS Group | Control Group |
|---|---|---|
| Ejection Fraction | 63 (62 to 64) | 63 (60 to 64) |
Death rate within 90 days after randomization.
| Participants | NS Group | Control Group |
|---|---|---|
| Death Rate | 2 | 5 |
Intracaranial hemorrhage confirmed by cranial CT within 7 days after randomization.
| Participants | NS Group | Control Group |
|---|---|---|
| Number of Paricipants With Intracaranial Hemorrhage | 7 | 3 |
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.
| Participants | NS Group | Control Group |
|---|---|---|
| Number of Participants With Symptomatic Intracranial Hemorrhage | 2 | 0 |
Peripheral blood inflammatory indices, neutrophil-to-lymphocyte ratio (NLR),24-48 hours after randomization.
| ratio | NS Group | Control Group |
|---|---|---|
| Neutrophil-to-lymphocyte Ratio (NLR) | 2.75 (1.96 to 3.87) | 2.63 (1.94 to 3.81) |
Peripheral blood inflammatory indices, platelet-to-lymphocyte (PLR) at 24-48 hours after randomization.
| ratio | NS Group | Control Group |
|---|---|---|
| Platelet-to-lymphocyte (PLR) | 135.70 (99.78 to 158.35) | 128.11 (100.71 to 159.30) |
Peripheral blood inflammatory indices, (platelet✖neurophil)/lymphocyte (SII) at 24-48 hours after randomization.
| ratio | NS Group | Control Group |
|---|---|---|
| SII | 527.05 (382.92 to 833.79) | 531.51 (426.70 to 796.46) |
Laboratory examinations, peripehral S100-β at 24-48 hours after randomization.
| ng/ml | NS Group | Control Group |
|---|---|---|
| S100-β | 2.17 ± 5.82 | 1.22 ± 2.19 |
Laboratory examinations, peripheral myeloperoxidase (MPO) at 24-48 hours after randomization.
| pg/ml | NS Group | Control Group |
|---|---|---|
| Myeloperoxidase (MPO) | 52746.41 ± 35023.82 | 53902.99 ± 47152.39 |
Laboratory examinations, brain derived neurotrophic factor (BDNF)at 24-48 hours after randomization.
| pg/ml | NS Group | Control Group |
|---|---|---|
| Brain Derived Neurotrophic Factor (BDNF) | 1019.59 ± 810.89 | 999.6 ± 817.42 |
Collected over through 90 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NS Group | 2/121 (1.7%) | 0/121 (0%) | 0/121 (0%) |
| Control Group | 5/120 (4.2%) | 0/120 (0%) | 0/120 (0%) |
| Age, Continuous(years) | NS Group | Control Group | Total |
|---|---|---|---|
| Median | 67.0 (60.5 to 71) | 66 (60 to 71) | 67 (60 to 71) |
| Sex: Female, Male(Participants) | NS Group | Control Group | Total |
|---|---|---|---|
| Female | 35 | 38 | 73 |
| Male | 86 | 82 | 168 |
| Race and Ethnicity Not Collected(Participants) | NS Group | Control Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | NS Group | Control Group | Total |
|---|---|---|---|
| China | 121 | 120 | 241 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — We will share study protocol and statistical analysis plan with other researchers.
Supporting information: Study protocol, Statistical analysis plan
Time frame: One years after publications.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Tianjin Medical University General Hospital