Normal Saline Infusion for Stroke After Intravenous Thrombolysis

NCT05993078 | Completed Phase 2 Results DMC

• 1 other identifier: NS-STAR
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 3

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 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

Keywords

brian infarction; thrombolysis; haemodilution; normal saline

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (20)

• NIHSS Scores at 24 Hours

  24 hours

• NIHSS Scores on Day 7

  7 days

• mRS on Day 7

  7 days

• mRS on Day 30

  30 days

• Number of Participants With Barthel Index 60-100 on Day 30

  30 days

Study Arms (2)

NS group

EXPERIMENTAL

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

Drug: 0.9% NaCl 2000ml

Control group

PLACEBO COMPARATOR

The patient will the patients receive an NS 200-400ml after IVT.

Drug: 0.9% NaCl 200-400ml

Interventions

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.

NS group

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.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead
• Affliated Hospital of Jiujiang University: collaborator
• Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine: collaborator

Study Sites (3)

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province

Cangzhou, Heibei, 061014, China

Location

Affiliated Hospital of Jiujiang University

Jiujiang, Jiangxi, 332000, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

MeSH Terms

Conditions

Brain Infarction

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Jiayue Ding
• Organization: Tianjin Medical University General Hospital

sjnkzz2@163.com

18518347837

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 15, 2023
• Study Start: September 1, 2023
• Primary Completion: December 20, 2024
• Study Completion: January 8, 2025
• Last Updated: March 12, 2025
• Results First Posted: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: One years after publications.

Locations

CN (3)