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NCT05914272

Association of Osmotic Drugs With Clinical Outcomes in Acute Large Hemispheric Infarction

Not yet recruiting Last updated 22 June 2023
What this trial tests

trial testing Osmotic drugs in Stroke in 2,592 participants. Not yet recruiting.

Timeline
1 July 2023
Primary endpoint
1 January 2027
1 January 2027

Quick facts

Lead sponsorNanfang Hospital, Southern Medical University
StatusNot yet recruiting
Study typeOBSERVATIONAL
Enrollment2,592
Start date1 July 2023
Primary completion1 January 2027
Estimated completion1 January 2027
Sites19 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Nanfang Hospital, Southern Medical University

Who can join

18 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Stroke remains the second leading cause of death worldwide, with 2%-8% of these being large hemispheric infarction (LHI) with an occupying effect and the worst prognosis. Even with medical and surgical treatment, the mortality of LHI with cerebral edema is as high as 20% to 30%. Current guidelines recommend supportive supervision, osmotic drugs, and decompressive hemicraniectomy (DHC) for the treatment of LHI, but not all patients with LHI are suitable for DHC, and not all of them can afford the high cost of DHC. In the real-world, the use of osmotic drugs is more common than DHC. The guideline recommends using mannitol or hypertonic saline to reduce cerebral edema and tissue displacement in patients with cerebral edema. Mannitol is the most widely used and longest-standing osmotic drug, and since 1965, hypertonic saline has been used to treat intracranial hypertension. Most of the previous studies compare the efficacy of DHC over medical therapy or compare the efficacy of mannitol with hypertonic saline, but there is an absence of clinical data on whether osmotic drug therapy can improve the clinical prognosis of patients with large hemispheric infarction at 90 days or even longer. Therefore, the purpose of this study was to investigate the association between the osmotic drug and clinical outcomes in large hemispheric infarction, with the aim of informing clinical decisions.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Stroke

Currently open trials in the same condition.

Other Nanfang Hospital, Southern Medical University trials

Trials by the same sponsor.

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Data sources for this page

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