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NCT07263308RecruitingPhase 3

Albumin for Patients With Acute Large Vessel Occlusive Stroke Undergoing Endovascular Therapy -2

Source: ClinicalTrials.gov · Last updated 29 Oct 2026

Brief summary (registry, in English)

This study is a prospective, multicenter, open-label, randomized controlled clinical trial. The investigators will apply albumin to the reperfusion treatment of patients with acute ischemic stroke in the anterior circulation. This study aims to verify the efficacy and safety of albumin combined with endovascular treatment in patients with anterior circulation acute ischemic stroke.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1192 (estimated)
First submitted
23 Nov 2025
Start date
18 Dec 2025
Primary completion date
20 Jun 2027
Lead sponsor
Capital Medical University
Diseases
Stroke
NCT number
NCT07263308

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1192
  • From 18 Dec 2025 to the primary completion date, 20 Jun 2027
  • 61 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

  • Patients who have participated in other interventional clinical studies within 30 days before randomization or are currently participating in other interventional clinical studies.

Other illness

  • Evidence of intracranial hemorrhage (intracerebral hematoma (ICH), subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT or MRI scan;
  • History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, thrombocytopenic diseases, etc;
  • Known severe allergy (more severe than skin rash) to contrast agents uncontrolled by medications;
  • An episode or exacerbation of congestive heart failure from any cause in the past 6 months;
  • History of heart valve disease complicated by congestive heart failure within the past 6 months;
  • Cardiac surgery with thoracotomy (eg. coronary artery bypass grafting or valve replacement surgery) within the past 6 months;
  • Acute myocardial infarction in the past 6 months;
  • Signs or symptoms of acute myocardial infarction upon admission, including electrocardiographic findings;
  • Acute arrhythmia (including any tachycardia or bradycardia) with hemodynamic instability (systolic blood pressure \<100 mm Hg) upon admission;
  • Acute or chronic lung diseases requiring long-term or intermittent oxygen therapy;
  • Findings on physical examination of any of the following abnormalities: (1) Jugular venous distension (jugular venous pulsation \>4 cm above the sternal angle); (2) Resting tachycardia due to congestive heart failure (heart rate \> 100 per/min); (3) Third heart sound; (4) Abnormal hepatic jugular venous reflux; (5) Pitting edema of the lower extremities attributable to congestive heart failure or without apparent cause; (6) Rales in both lungs; (7) Or evidence of pulmonary edema, pleural effusion, or pulmonary vascular redistribution on chest X-ray;
  • Refractory hypertension that is difficult to control by medication (defined as systolic blood pressure \> 220 mmHg, or diastolic blood pressure \> 110 mmHg);
  • Patients with severe mental disorders or dementia who are unable to cooperate in completing informed consent and follow-up content;
  • The expected survival time is less than 90 days (such as comorbidity with malignant tumor or severe systemic diseases etc.);
  • The investigator believes that the subject has other conditions making it unsuitable for participating in this study.

Lab values

  • Elevated serum troponin concentration upon admission (\>0.1 μg/L) ;
  • Severe chronic anemia (hemoglobin \< 75 g/L);
  • Known recent or current serum creatinine exceeding 1.5 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) \< 60 mL/min;
  • Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is greater than 1.5 times the upper limit of the normal value.
  • History of albumin allergy or known allergy to albumin;

Other

  • Anticipated difficulty in completing endovascular treatment due to vascular tortuosity;
  • Pregnancy, breastfeeding;

Who the study is looking for

  • Age between 18 and 80 years;
  • Acute ischemic stroke with indications for endovascular treatment within 24 hours of onset;
  • Anterior circulation acute ischemic stroke, with acute occlusion of the responsible vessel located in the intracranial segment of the internal carotid artery, or the M1 or M2 segment of the middle cerebral artery;
  • National Institute of Health Stroke Scale (NIHSS) score \>=6;
  • Alberta Stroke Program Early CT Score (ASPECTS) \>=3 points;
  • Modified Rankin Scale (mRS) score ≤4 before onset of the disease;
  • Written informed consent provided by the patients or their legal relatives.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (61)

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

SiteCityCountrySite status
Susong County Hospital of Traditional Chinese Medicine
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AnqingChinaRecruiting
Baoding NO.1 Central Hospital
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BaodingChinaRecruiting
Xuanwu Hospital, Capital Medical University
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BeijingChinaRecruiting
People's Hospital of Bortala Mongol Autonomous Prefecture
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BoleChinaRecruiting
Bozhou People's Hospital
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BozhouChinaRecruiting
Cenxi People's Hospital
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CenxiChinaRecruiting
Changde First People's Hospital
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ChangdeChinaRecruiting
Changzhou Fourth People's Hospital
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ChangzhouChinaRecruiting
Dongguan Eastern Central Hospital
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DongguanChinaRecruiting
Dongguan People's Hospital
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DongguanChinaRecruiting
Feicheng Hospital Of Shandong Yiyang Health Group
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FeichengChinaRecruiting
Sanshui Hospital of Zhujiang Hospital, Southern Medical University
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FoshanChinaRecruiting
Taihe County Hospital of Traditional Chinese Medicine
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FuyangChinaRecruiting
Fujian Medical University Union Hospital
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FuzhouChinaRecruiting
Liuyang Jili Hospital
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GuankouChinaRecruiting
Guiyang Fourth People's Hospital
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GuiyangChinaRecruiting
Heyuan People's Hospital
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HeyuanChinaRecruiting
Huazhou People's Hospital
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HuazhouChinaRecruiting
Huiyang Sanhe Hospital
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HuizhouChinaRecruiting
Jiamusi University Hongda Hospital
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JiamusiChinaRecruiting
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
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JinanChinaRecruiting
Shanghai General Hospital Jiuquan Hospital
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JiuquanChinaRecruiting
Jixi People's Hospital
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JixiChinaRecruiting
People's Hospital of Bayingolin Mongolian Autonomous Prefecture
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KorlaChinaRecruiting
Gansu Provincial Hospital
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LanzhouChinaRecruiting
PLA Joint Logistic Support Force 940th Hospital
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LanzhouChinaRecruiting
Linyi People's Hospital
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LinyiChinaRecruiting
Luoyang Central Hospital
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LuoyangChinaRecruiting
Luoding People's Hospital
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LuoyangChinaRecruiting
Ma'anshan People's Hospital
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Ma’anshanChinaRecruiting
Meishan Second People's Hospital
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MeishanChinaRecruiting
Sichuan Science City Hospital
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MianyangChinaRecruiting
Nanbu County People's Hospital
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Nanbu CountyChinaRecruiting
Donggang Central Hospital
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NanchongChinaRecruiting
Nanyang First People's Hospital
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NanyangChinaRecruiting
Pingdingshan Second People's Hospital
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PingdingshanChinaRecruiting
Huize County People's Hospital
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QujingChinaRecruiting
Rizhao Hospital of Traditional Chinese Medicine
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RizhaoChinaRecruiting
Ningling County People's Hospital
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ShangqiuChinaRecruiting
The First Affiliated Hospital of Shaoyang University
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ShaoyangChinaRecruiting
Daliuta Experimental Area Hospital of Shenmu City
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ShenmuChinaRecruiting
Taihe Hospital, Hubei University of Medicine
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ShiyanChinaRecruiting
Si County People's Hospital
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SuzhouChinaRecruiting
Kailuan General Hospital Linxi Hospital
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TangshanChinaRecruiting
Tianmen First People's Hospital
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TianmenChinaRecruiting
The First Affiliated Hospital of Xinxiang Medical University
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WeihuiChinaRecruiting
Wuhu Second People's Hospital
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WuhuChinaRecruiting
Wuwei People's Hospital
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WuhuChinaRecruiting
Yan'an University Xianyang Hospital
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XianyangChinaRecruiting
Xuzhou Cancer Hospital
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XuzhouChinaRecruiting
PLA Joint Logistic Support Force 970th Hospital
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YantaiChinaRecruiting
Laizhou People's Hospital
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YantaiChinaRecruiting
Yiyang Central Hospital
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YiyangChinaRecruiting
Yuncheng Central Hospital
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YunchengChinaRecruiting
Zhangzhou Hospital
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ZhangzhouChinaRecruiting
Zhengzhou Central Hospital Affiliated to Zhengzhou University
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ZhengzhouChinaRecruiting
Zhongmou County People's Hospital
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ZhengzhouChinaRecruiting
Zhoukou Central Hospital
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ZhoukouChinaRecruiting
Xihua County People's Hospital
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ZhoukouChinaRecruiting
Shenqiu County People's Hospital
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ZhoukouChinaRecruiting
Yiyuan County People's Hospital
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ZiboChinaRecruiting

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