Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Affliated Hospital of Jiujiang University | UNKNOWN |
| Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NS group | Experimental | The patient will undergo NS 2000ml intravenous infusion immediately after IVT. |
|
| Control group | Placebo Comparator | The patient will the patients receive an NS 200-400ml after IVT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.9% NaCl 2000ml | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24 hours |
Not provided
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 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province | Cangzhou | Heibei | 061014 | China | ||
We will share study protocol and statistical analysis plan with other researchers.
One years after publications.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | NS Group | The patient will undergo NS 2000ml intravenous infusion immediately after IVT. |
| FG001 | Control Group | The patient will the patients receive an NS 200-400ml after IVT. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | NS Group | The patient will undergo NS 2000ml intravenous infusion immediately after IVT. |
| BG001 | Control Group | The patient will the patients receive an NS 200-400ml after IVT. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | One patient in each group was lost to follow-up at 90 days. | Posted | Count of Participants | Participants | 90 days |
|
through 90 days
Adverse events include all death, serious adverse events and other adverse events. Serous adverse events comprise (1) fatal; (2) life-threatening; (3) causing or prolonging hospitalization; (4) disability or organ function impairment. Other adverse events include acute heart failure, hypertensive crisis, edema (such as severe cerebral edema, pulmonary edema, limb edema and water intoxication) and other severe complications.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NS Group | The patient will undergo NS 2000ml intravenous infusion immediately after IVT. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jiayue Ding | Tianjin Medical University General Hospital | 18518347837 | sjnkzz2@163.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 28, 2023 | Feb 5, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D020520 | Brain Infarction |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 0.9% NaCl 200-400ml | Drug | 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. |
|
| 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). |
| 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. | 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. | 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. | 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. | 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. | 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. | 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/). | 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. | 24 hours |
| Ejection Fraction | Ejection fraction was assessed by ultrasonic cardiogram within 72 hours after randomization. | 72 hours |
| Death Rate | Death rate within 90 days after randomization. | 90 days |
| Number of Paricipants With Intracaranial Hemorrhage | Intracaranial hemorrhage confirmed by cranial CT within 7 days after randomization. | 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. | 7 days |
| Neutrophil-to-lymphocyte Ratio (NLR) | Peripheral blood inflammatory indices, neutrophil-to-lymphocyte ratio (NLR),24-48 hours after randomization. | 24-48 hours |
| Platelet-to-lymphocyte (PLR) | Peripheral blood inflammatory indices, platelet-to-lymphocyte (PLR) at 24-48 hours after randomization. | 24-48 hours |
| SII | Peripheral blood inflammatory indices, (platelet✖neurophil)/lymphocyte (SII) at 24-48 hours after randomization. | 24-48 hours |
| S100-β | Laboratory examinations, peripehral S100-β at 24-48 hours after randomization. | 24-48 hours |
| Myeloperoxidase (MPO) | Laboratory examinations, peripheral myeloperoxidase (MPO) at 24-48 hours after randomization. | 24-48 hours |
| Brain Derived Neurotrophic Factor (BDNF) | Laboratory examinations, brain derived neurotrophic factor (BDNF)at 24-48 hours after randomization. | 24-48 hours |
| Affiliated Hospital of Jiujiang University |
| Jiujiang |
| Jiangxi |
| 332000 |
| China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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). | Posted | Median | Inter-Quartile Range | score on a scale | 24 hours |
|
|
|
| Secondary | 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). | Posted | Median | Inter-Quartile Range | score on scale | 7 days |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on scale | 7 days |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 30 days |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Secondary | 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/). | Posted | Median | Inter-Quartile Range | ml | 24 hours |
|
|
|
| Secondary | Blood Pressure at 24 Hours | Blood pressure, including systolic blood pressure (SBP) and diastolic blood pressure (DBP), is monitored at 24 hours after randomization. | Posted | Median | Inter-Quartile Range | mmHg | 24 hours |
|
|
|
| Secondary | Ejection Fraction | Ejection fraction was assessed by ultrasonic cardiogram within 72 hours after randomization. | Posted | Median | Inter-Quartile Range | percentage | 72 hours |
|
|
|
| Secondary | Death Rate | Death rate within 90 days after randomization. | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Number of Paricipants With Intracaranial Hemorrhage | Intracaranial hemorrhage confirmed by cranial CT within 7 days after randomization. | Posted | Count of Participants | Participants | 7 days |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 7 days |
|
|
|
| Secondary | Neutrophil-to-lymphocyte Ratio (NLR) | Peripheral blood inflammatory indices, neutrophil-to-lymphocyte ratio (NLR),24-48 hours after randomization. | Posted | Median | Inter-Quartile Range | ratio | 24-48 hours |
|
|
|
| Secondary | Platelet-to-lymphocyte (PLR) | Peripheral blood inflammatory indices, platelet-to-lymphocyte (PLR) at 24-48 hours after randomization. | Posted | Median | Inter-Quartile Range | ratio | 24-48 hours |
|
|
|
| Secondary | SII | Peripheral blood inflammatory indices, (platelet✖neurophil)/lymphocyte (SII) at 24-48 hours after randomization. | Posted | Median | Inter-Quartile Range | ratio | 24-48 hours |
|
|
|
| Secondary | S100-β | Laboratory examinations, peripehral S100-β at 24-48 hours after randomization. | Posted | Mean | Standard Deviation | ng/ml | 24-48 hours |
|
|
|
| Secondary | Myeloperoxidase (MPO) | Laboratory examinations, peripheral myeloperoxidase (MPO) at 24-48 hours after randomization. | Posted | Mean | Standard Deviation | pg/ml | 24-48 hours |
|
|
|
| Secondary | Brain Derived Neurotrophic Factor (BDNF) | Laboratory examinations, brain derived neurotrophic factor (BDNF)at 24-48 hours after randomization. | Posted | Mean | Standard Deviation | pg/ml | 24-48 hours |
|
|
|
| 2 |
| 121 |
| 0 |
| 121 |
| 0 |
| 121 |
| EG001 | Control Group | The patient will the patients receive an NS 200-400ml after IVT. | 5 | 120 | 0 | 120 | 0 | 120 |
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |