Health TrialsbyHealthPanel

Normal Saline Infusion After Intravenous Thrombolysis in Stroke

ConditionBrain Infarction
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTianjin Medical University General Hospital

About this trial

The intravenous administration of abundant normal saline is an easy-to-use strategy commonly employed to expand the blood volume. This study aimed to evaluate the efficacy and safety of the early administration of an abundant normal saline infusion after intravenous thrombolysis for promoting functional independence in patients with acute ischemic stroke. This multicenter, randomized, phase III clinical trial intends to enroll stroke participants who have undergone intravenous thrombolysis. Eligible patients are randomized to receive either abundant intravenous normal saline infusion (2,000-2,500 mL; normal saline group) or a small volume of intravenous normal saline infusion (≤600 mL; control group) immediately after thrombolysis. The primary outcome is the comparison of the ordinal modified Rankin Scale score at 90 days (±3) after randomization between the treatment groups.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 80 years.

Acute ischemic stroke treated with intravenous thrombolysis.

Prestroke mordified Rankin Scale score ≤1;

Admission NIHSS score 4-25, with NIHSS 4-5 requiring the presence of a disabling deficit as defined in the 2026 AHA/ASA Guideline for the Early Management of Patients With Acute Ischemic Stroke.

Disqualifiers

Contraindications to intravenous thrombolysis.

Planned endovascular treatment prior to enrollment.

History of heart failure, or pre-enrollment brain natriuretic peptide (BNP) ≥100 pg/mL, or clinical presentations or signs suggestive of heart failure.

History of atrial fibrillation, or pre-enrollment electrocardiogram indicating atrial fibrillation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • normal saline

    Drug

    The participants will undergo 2,000-2,500 mL normal saline intravenous infusion immediately after intravenous thrombolysis.

  • normal saline

    Drug

    The participants will receive ≤600 mL of normal saline infusion after intravenous thrombolysis.

Treatment groups

752 Participants
are divided into 2 treatment groups
Group A: Normal saline groupExperimental treatment 1 intervention
Group B: Control groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

The modified Rankin Scale distribution

The ordinal scores on the modified Rankin Scale range from 0 to 6, with higher scores indicating worse outcomes.

Time frame
90 days (±3)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University General Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: