Normal Saline Infusion for Stroke After Intravenous Thrombolysis
Brain Infarct
Bottom Line
View on ClinicalTrials.gov: NCT05993078 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 0.9% NaCl 2000ml (Drug); 0.9% NaCl 200-400ml (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tianjin Medical University General Hospital
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With 90-day Favorable Outcome |
106; 93 | — |
| SECONDARY NIHSS Scores at 24 Hours |
2; 2 | — |
| SECONDARY NIHSS Scores on Day 7 |
1; 1 | — |
| SECONDARY mRS on Day 7 |
1; 1 | — |
| SECONDARY mRS on Day 30 |
1; 1 | — |
| SECONDARY Number of Participants With Barthel Index 60-100 on Day 30 |
108; 104 | — |
| SECONDARY Number of Participants With Barthel Index 60-100 on Day 90 |
111; 105 | — |
| SECONDARY Number of Pariticipants With Early Neurological Deterioration (END, △NIHSS≥2) |
10; 25 | — |
| SECONDARY Number of Participants With Early Neurological Deterioration (END, △NIHSS≥4) |
8; 19 | — |
| SECONDARY Imaging Infarction Volume at 24 Hours |
0.21; 0.31 | — |
| SECONDARY Blood Pressure at 24 Hours |
142; 135; 79; 77 | — |
| SECONDARY Ejection Fraction |
63; 63 | — |
| SECONDARY Death Rate |
2; 5 | — |
| SECONDARY Number of Paricipants With Intracaranial Hemorrhage |
7; 3 | — |
| SECONDARY Number of Participants With Symptomatic Intracranial Hemorrhage |
2; 0 | — |
| SECONDARY Neutrophil-to-lymphocyte Ratio (NLR) |
2.75; 2.63 | — |
| SECONDARY Platelet-to-lymphocyte (PLR) |
135.70; 128.11 | — |
| SECONDARY SII |
527.05; 531.51 | — |
| SECONDARY S100-β |
2.17; 1.22 | — |
| SECONDARY Myeloperoxidase (MPO) |
52746.41; 53902.99 | — |
| SECONDARY Brain Derived Neurotrophic Factor (BDNF) |
1019.59; 999.6 | — |
Summary
Eligibility Criteria
Inclusion criteria
- AIS;
- Age 18-80 years;
- Prestroke mRS≤1;
- NIHSS score 0-25;
- Onset-to-needle time≤4.5 h;
- Sign the informed consent. Exclusion 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 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 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.
Data sourced from ClinicalTrials.gov (NCT05993078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.