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NCT05914272Not yet recruiting

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

Association of Osmotic Drugs With Clinical Outcomes in Acute Large Hemispheric Infarction: a Prospective, Multicenter, Observational Cohort Study

Source: ClinicalTrials.gov · Last updated 22 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
2592 (estimated)
First submitted
26 Apr 2023
Start date
1 Jul 2023
Primary completion date
1 Jan 2027
Lead sponsor
Nanfang Hospital, Southern Medical University
Diseases
Stroke
NCT number
NCT05914272

What you commit to

  • Study type: Observational
  • Planned participants: 2592
  • From 1 Jul 2023 to the primary completion date, 1 Jan 2027
  • 19 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Those with a previous history of stroke and significant residual neurological disability (mRS ≥ 2 points)

Other illness

  • Those who are allergic or intolerant to osmotic drugs;

Other

  • Women who are pregnant or breastfeeding;
  • in combination with other serious comorbidities resulting in a life expectancy of less than 3 months
  • Those who have participated in other interventional clinical studies (which affecting the observation of outcomes in this cohort);
  • Those who, in the judgment of the investigator, are not suitable for participation in this study

Who the study is looking for

  • Age ≥ 18 years
  • Within 72 hours of onset of the stroke
  • Meets the diagnostic criteria for acute ischaemic stroke in the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018"
  • Meeting the diagnostic criteria for massive cerebral infarction in the "Guidelines for the Surgical Treatment of Massive Cerebral Infarction": CT within 6 hours of onset showing hypointense areas \> 1/3 of the middle cerebral artery territory, or \> 50% of the middle cerebral artery territory within 6 hours to 72 hours of onset;
  • The patient consented and signed an informed consent form.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sinopharm North Hospital
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BaotouChinaUnknown status
The First Hospital of Changsha
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ChangshaChinaUnknown status
Dongguan People's Hospital
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DongguanChinaUnknown status
Dongguan Donghua Hospital
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DongguanChinaUnknown status
Fujian Medical University Union Hospital
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FuzhouChinaUnknown status
Ganzhou City People's Hospital
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GanzhouChinaUnknown status
The Fourth Affiliated Hospital of Guangzhou Medical University
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GuangzhouChinaUnknown status
Guangdong Provincial Hospital of Traditional Chinese Medicine
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GuangzhouChinaUnknown status
Huadu District People's Hospital of Guangzhou
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GuangzhouChinaUnknown status
Haikou People's Hospital
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HaikouChinaUnknown status
Hainan People's Hospital
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HaikouChinaUnknown status
Hainan Traditional Chinese Medicine Hospital
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HaikouChinaUnknown status
The Second Hospital University of South China
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HengyangChinaUnknown status
Heyuan People's Hospital
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HeyuanChinaUnknown status
The Affiliated Hospital of Inner Mongolia Medical University
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HohhotChinaUnknown status
Huizhou Municipal Central Hospital
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HuizhouChinaUnknown status
Kashgar 1st People's Hospital
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KashgarChinaUnknown status
Second Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaUnknown status
Yueyang People's Hospital
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YueyangChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.