Trial Outcomes & Findings for Normal Saline Infusion for Stroke After Intravenous Thrombolysis (NCT NCT05993078)

NCT ID: NCT05993078

Last Updated: 2025-03-12

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 241 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2025-03-12

Participant Flow

Participant milestones

Measure	NS Group The patient will undergo NS 2000ml intravenous infusion immediately after IVT.	Control Group The patient will the patients receive an NS 200-400ml after IVT.
Overall Study STARTED	121	120
Overall Study COMPLETED	121	120
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	NS Group n=121 Participants The patient will undergo NS 2000ml intravenous infusion immediately after IVT.	Control Group n=120 Participants The patient will the patients receive an NS 200-400ml after IVT.	Total n=241 Participants Total of all reporting groups
Age, Continuous	67.0 years n=121 Participants	66 years n=120 Participants	67 years n=241 Participants
Sex: Female, Male Female	35 Participants n=121 Participants	38 Participants n=120 Participants	73 Participants n=241 Participants
Sex: Female, Male Male	86 Participants n=121 Participants	82 Participants n=120 Participants	168 Participants n=241 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment China	121 participants n=121 Participants	120 participants n=120 Participants	241 participants n=241 Participants

PRIMARY outcome

Timeframe: 90 days

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

Outcome measures

Measure	NS Group n=120 Participants The patient will undergo NS 2000ml intravenous infusion immediately after IVT.	Control Group n=119 Participants The patient will the patients receive an NS 200-400ml after IVT.
Number of Participants With 90-day Favorable Outcome	106 Participants	93 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	NS Group n=121 Participants The patient will undergo NS 2000ml intravenous infusion immediately after IVT.	Control Group n=120 Participants The patient will the patients receive an NS 200-400ml after IVT.
NIHSS Scores at 24 Hours	2 score on a scale Interval 0.0 to 4.0	2 score on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: 7 days

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).

Outcome measures

Measure	NS Group n=120 Participants The patient will undergo NS 2000ml intravenous infusion immediately after IVT.	Control Group n=114 Participants The patient will the patients receive an NS 200-400ml after IVT.
NIHSS Scores on Day 7	1 score on scale Interval 0.0 to 3.0	1 score on scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: 7 days

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.

Outcome measures

Measure	NS Group n=121 Participants The patient will undergo NS 2000ml intravenous infusion immediately after IVT.	Control Group n=117 Participants The patient will the patients receive an NS 200-400ml after IVT.
mRS on Day 7	1 score on scale Interval 0.0 to 2.0	1 score on scale Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: 30 days

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.

Outcome measures

Measure	NS Group n=121 Participants The patient will undergo NS 2000ml intravenous infusion immediately after IVT.	Control Group n=120 Participants The patient will the patients receive an NS 200-400ml after IVT.
mRS on Day 30	1 score on a scale Interval 0.0 to 2.0	1 score on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 30 days

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.

Outcome measures

Measure	NS Group n=120 Participants The patient will undergo NS 2000ml intravenous infusion immediately after IVT.	Control Group n=116 Participants The patient will the patients receive an NS 200-400ml after IVT.
Number of Participants With Barthel Index 60-100 on Day 30	108 Participants	104 Participants

SECONDARY outcome

Timeframe: 90 days

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.

Outcome measures

Measure	NS Group n=118 Participants The patient will undergo NS 2000ml intravenous infusion immediately after IVT.	Control Group n=114 Participants The patient will the patients receive an NS 200-400ml after IVT.
Number of Participants With Barthel Index 60-100 on Day 90	111 Participants	105 Participants

SECONDARY outcome

Timeframe: 24 hours

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.

Outcome measures

Measure	NS Group n=120 Participants The patient will undergo NS 2000ml intravenous infusion immediately after IVT.	Control Group n=120 Participants The patient will the patients receive an NS 200-400ml after IVT.
Number of Pariticipants With Early Neurological Deterioration (END, △NIHSS≥2)	10 Participants	25 Participants

SECONDARY outcome

Timeframe: 24 hours

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.

Outcome measures

Measure	NS Group n=120 Participants The patient will undergo NS 2000ml intravenous infusion immediately after IVT.	Control Group n=120 Participants The patient will the patients receive an NS 200-400ml after IVT.
Number of Participants With Early Neurological Deterioration (END, △NIHSS≥4)	8 Participants	19 Participants

SECONDARY outcome

Timeframe: 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/).

Outcome measures

Measure	NS Group n=121 Participants The patient will undergo NS 2000ml intravenous infusion immediately after IVT.	Control Group n=118 Participants The patient will the patients receive an NS 200-400ml after IVT.
Imaging Infarction Volume at 24 Hours	0.21 ml Interval 0.0 to 2.52	0.31 ml Interval 0.0 to 1.82

SECONDARY outcome

Timeframe: 24 hours

Blood pressure, including systolic blood pressure (SBP) and diastolic blood pressure (DBP), is monitored at 24 hours after randomization.

Outcome measures

Measure	NS Group n=121 Participants The patient will undergo NS 2000ml intravenous infusion immediately after IVT.	Control Group n=120 Participants The patient will the patients receive an NS 200-400ml after IVT.
Blood Pressure at 24 Hours systolic pressure	142 mmHg Interval 133.0 to 158.0	135 mmHg Interval 123.0 to 148.0
Blood Pressure at 24 Hours diastolic pressure	79 mmHg Interval 72.0 to 87.0	77 mmHg Interval 71.0 to 83.0

SECONDARY outcome

Timeframe: 72 hours

Ejection fraction was assessed by ultrasonic cardiogram within 72 hours after randomization.

Outcome measures

Measure	NS Group n=111 Participants The patient will undergo NS 2000ml intravenous infusion immediately after IVT.	Control Group n=92 Participants The patient will the patients receive an NS 200-400ml after IVT.
Ejection Fraction	63 percentage Interval 62.0 to 64.0	63 percentage Interval 60.0 to 64.0

SECONDARY outcome

Timeframe: 90 days

Death rate within 90 days after randomization.

Outcome measures

Measure	NS Group n=120 Participants The patient will undergo NS 2000ml intravenous infusion immediately after IVT.	Control Group n=119 Participants The patient will the patients receive an NS 200-400ml after IVT.
Death Rate	2 Participants	5 Participants

SECONDARY outcome

Timeframe: 7 days

Intracaranial hemorrhage confirmed by cranial CT within 7 days after randomization.

Outcome measures

Measure	NS Group n=121 Participants The patient will undergo NS 2000ml intravenous infusion immediately after IVT.	Control Group n=120 Participants The patient will the patients receive an NS 200-400ml after IVT.
Number of Paricipants With Intracaranial Hemorrhage	7 Participants	3 Participants

SECONDARY outcome

Timeframe: 7 days

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.

Outcome measures

Measure	NS Group n=121 Participants The patient will undergo NS 2000ml intravenous infusion immediately after IVT.	Control Group n=120 Participants The patient will the patients receive an NS 200-400ml after IVT.
Number of Participants With Symptomatic Intracranial Hemorrhage	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 24-48 hours

Peripheral blood inflammatory indices, neutrophil-to-lymphocyte ratio (NLR),24-48 hours after randomization.

Outcome measures

Measure	NS Group n=114 Participants The patient will undergo NS 2000ml intravenous infusion immediately after IVT.	Control Group n=110 Participants The patient will the patients receive an NS 200-400ml after IVT.
Neutrophil-to-lymphocyte Ratio (NLR)	2.75 ratio Interval 1.96 to 3.87	2.63 ratio Interval 1.94 to 3.81

SECONDARY outcome

Timeframe: 24-48 hours

Peripheral blood inflammatory indices, platelet-to-lymphocyte (PLR) at 24-48 hours after randomization.

Outcome measures

Measure	NS Group n=114 Participants The patient will undergo NS 2000ml intravenous infusion immediately after IVT.	Control Group n=110 Participants The patient will the patients receive an NS 200-400ml after IVT.
Platelet-to-lymphocyte (PLR)	135.70 ratio Interval 99.78 to 158.35	128.11 ratio Interval 100.71 to 159.3

SECONDARY outcome

Timeframe: 24-48 hours

Peripheral blood inflammatory indices, (platelet✖neurophil)/lymphocyte (SII) at 24-48 hours after randomization.

Outcome measures

Measure	NS Group n=114 Participants The patient will undergo NS 2000ml intravenous infusion immediately after IVT.	Control Group n=110 Participants The patient will the patients receive an NS 200-400ml after IVT.
SII	527.05 ratio Interval 382.92 to 833.79	531.51 ratio Interval 426.7 to 796.46

SECONDARY outcome

Timeframe: 24-48 hours

Laboratory examinations, peripehral S100-β at 24-48 hours after randomization.

Outcome measures

Measure	NS Group n=110 Participants The patient will undergo NS 2000ml intravenous infusion immediately after IVT.	Control Group n=88 Participants The patient will the patients receive an NS 200-400ml after IVT.
S100-β	2.17 ng/ml Standard Deviation 5.82	1.22 ng/ml Standard Deviation 2.19

SECONDARY outcome

Timeframe: 24-48 hours

Laboratory examinations, peripheral myeloperoxidase (MPO) at 24-48 hours after randomization.

Outcome measures

Measure	NS Group n=110 Participants The patient will undergo NS 2000ml intravenous infusion immediately after IVT.	Control Group n=88 Participants The patient will the patients receive an NS 200-400ml after IVT.
Myeloperoxidase (MPO)	52746.41 pg/ml Standard Deviation 35023.82	53902.99 pg/ml Standard Deviation 47152.39

SECONDARY outcome

Timeframe: 24-48 hours

Laboratory examinations, brain derived neurotrophic factor (BDNF)at 24-48 hours after randomization.

Outcome measures

Measure	NS Group n=107 Participants The patient will undergo NS 2000ml intravenous infusion immediately after IVT.	Control Group n=77 Participants The patient will the patients receive an NS 200-400ml after IVT.
Brain Derived Neurotrophic Factor (BDNF)	1019.59 pg/ml Standard Deviation 810.89	999.6 pg/ml Standard Deviation 817.42

Adverse Events

NS Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jiayue Ding

Tianjin Medical University General Hospital

Phone: 18518347837

Email: sjnkzz2@163.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place