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Normal Saline Infusion for Stroke After Intravenous Thrombolysis (NS-STAR)

Primary Purpose

Brain Infarct

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
0.9% NaCl 2000ml
0.9% NaCl 0ml
Sponsored by
Tianjin Medical University General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Infarct focused on measuring brian infarction, thrombolysis, haemodilution, normal saline

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Acute ischemic stroke (AIS) Age 18-80 years Pre-stroke mRS≤1 Onset-to-needle time≤4.5 hours Treated with alteplase Initial diagnosis of penetrating artery disease, large artery atherosclerosis (LAA) inducing parent artery (plaque or thrombus) occluding penetrating artery and LAA inducing hypoperfusion defined by Chinese ischemic stroke subclassification (CISS) system Sign the informed consent Exclusion Criteria: Severe AIS, including NIHSS score>20 in dominant hemisphere infarction, or NIHSS score>15 in non-dominant hemisphere infarction, or NIHSS consciousness score >1 Massive infarction, characterized by infarction area larger than 1/3 of the effected middle cerebral artery (MCA) territory and/or the cerebellum territory presented in admitted CT or MRI Initial diagnosis of LAA inducing artery-to-artery embolism, cardiogenic stroke, other etiologies and undetermined etiologies defined by CISS system Intention to undergo endovascular treatment Intention to undergo antiplatelet drugs within 24 hours after IVT, such as aspirin, clopidogrel, ticagrelor, cilostazol and tirofiban Allergy to alteplase 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 Cerebral infarction or myocardial infarction within previous 3 months, previous intracranial haemorrhage (ICH) including parenchymal haemorrhage, intraventricular haemorrhage, subarachnoid haemorrhage, subdural/external haematoma, etc Severe brain trauma, intracranial or intraspinal surgery within previous 3 months or known malignant intracranial neoplasm, giant intracranial aneurysm or arteriovenous malformation Persistent systolic blood pressure≥180mmHg or diastolic blood pressure≥100mmHg Admitted blood glucose<2.8mmol/L or >22.22mmol/L 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 Platelet count<100×109/L Stroke mimics, such as seizure and hysteria Brain haemorrhage identified by CT or MRI Any terminal illness such that patients would not be expected to survive>1 year Pregnant women or nursing mother Poor compliance Participating in other clinical trials within previous 3 months.

Sites / Locations

  • Tianjin Medical University General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NS group

Control group

Arm Description

The patient will undergo NS 2000ml intravenous infusion swiftly after IVT.

The patient will not undergo 0.9% NaCl intravenous infusion after IVT.

Outcomes

Primary Outcome Measures

90-day favorable outcome
Disability at days 90, as scored by means of the modified Rankin scale (mRS), dichotomized as a favorable outcome (a score of 0 or 1), or an unfavorable outcome (a score of 2 to 6). Scores on mRS range from 0 (no symptoms at all) to 6 (death), with higher values reflecting more severe disability or death.

Secondary Outcome Measures

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).
NIHSS scores at days 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).
mRS at days 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.
mRS at days 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.
volume of infarction at 24 hours
early neurological deterioration
Early neurological deterioration indicates an increase of 4 or more points on 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.

Full Information

First Posted
August 3, 2023
Last Updated
October 19, 2023
Sponsor
Tianjin Medical University General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05993078
Brief Title
Normal Saline Infusion for Stroke After Intravenous Thrombolysis
Acronym
NS-STAR
Official Title
Safety and Efficacy of Immediate Normal Saline Infusion for Stroke After Intravenous Thrombolysis (NS-STAR): a Protocol of Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Medical University General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 NS group and control group randomly after confirming as acute ischemic stroke (AIS) according to symptoms and signs. In NS group, the patient will undergo NS 2000ml intravenous infusion swiftly after IVT, with the speed of 200ml/h. In control group, the patient will not undergo NS intravenous infusion 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 or 1), or an unfavorable outcome (a score of 2 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. Stata 15.1 and R software will be used for statistical analysis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Infarct
Keywords
brian infarction, thrombolysis, haemodilution, normal saline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NS group
Arm Type
Experimental
Arm Description
The patient will undergo NS 2000ml intravenous infusion swiftly after IVT.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The patient will not undergo 0.9% NaCl intravenous infusion after IVT.
Intervention Type
Drug
Intervention Name(s)
0.9% NaCl 2000ml
Intervention Description
The patient will undergo NS 2000ml intravenous infusion swiftly after IVT.
Intervention Type
Drug
Intervention Name(s)
0.9% NaCl 0ml
Intervention Description
The patient will not undergo 0.9% NaCl intravenous infusion after IVT.
Primary Outcome Measure Information:
Title
90-day favorable outcome
Description
Disability at days 90, as scored by means of the modified Rankin scale (mRS), dichotomized as a favorable outcome (a score of 0 or 1), or an unfavorable outcome (a score of 2 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
Secondary Outcome Measure Information:
Title
NIHSS scores at 24 hours
Description
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
Title
NIHSS scores at days 7
Description
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
Title
mRS at days 7
Description
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
Title
mRS at days 30
Description
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
Title
volume of infarction at 24 hours
Time Frame
24 hours
Title
early neurological deterioration
Description
Early neurological deterioration indicates an increase of 4 or more points on 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute ischemic stroke (AIS) Age 18-80 years Pre-stroke mRS≤1 Onset-to-needle time≤4.5 hours Treated with alteplase Initial diagnosis of penetrating artery disease, large artery atherosclerosis (LAA) inducing parent artery (plaque or thrombus) occluding penetrating artery and LAA inducing hypoperfusion defined by Chinese ischemic stroke subclassification (CISS) system Sign the informed consent Exclusion Criteria: Severe AIS, including NIHSS score>20 in dominant hemisphere infarction, or NIHSS score>15 in non-dominant hemisphere infarction, or NIHSS consciousness score >1 Massive infarction, characterized by infarction area larger than 1/3 of the effected middle cerebral artery (MCA) territory and/or the cerebellum territory presented in admitted CT or MRI Initial diagnosis of LAA inducing artery-to-artery embolism, cardiogenic stroke, other etiologies and undetermined etiologies defined by CISS system Intention to undergo endovascular treatment Intention to undergo antiplatelet drugs within 24 hours after IVT, such as aspirin, clopidogrel, ticagrelor, cilostazol and tirofiban Allergy to alteplase 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 Cerebral infarction or myocardial infarction within previous 3 months, previous intracranial haemorrhage (ICH) including parenchymal haemorrhage, intraventricular haemorrhage, subarachnoid haemorrhage, subdural/external haematoma, etc Severe brain trauma, intracranial or intraspinal surgery within previous 3 months or known malignant intracranial neoplasm, giant intracranial aneurysm or arteriovenous malformation Persistent systolic blood pressure≥180mmHg or diastolic blood pressure≥100mmHg Admitted blood glucose<2.8mmol/L or >22.22mmol/L 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 Platelet count<100×109/L Stroke mimics, such as seizure and hysteria Brain haemorrhage identified by CT or MRI Any terminal illness such that patients would not be expected to survive>1 year Pregnant women or nursing mother Poor compliance Participating in other clinical trials within previous 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiayue Ding, Prof
Phone
+8618518347837
Email
sjnkzz2@163.com
Facility Information:
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiayue Ding, Prof
Phone
+8618518347837
Email
sjnkzz2@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will share study protocol and statistical analysis plan with other researchers.
IPD Sharing Time Frame
One years after publications.

Learn more about this trial

Normal Saline Infusion for Stroke After Intravenous Thrombolysis

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