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Could a simple protein boost stroke recovery? major trial underway

NCT ID NCT07263308

Disease control Sponsor: Capital Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 4 times

Summary

This study tests whether giving the protein albumin (given as an IV drip for four days) along with standard clot-removal treatment helps people recover better after a severe stroke caused by a large blockage. About 1,200 adults aged 18-80 with anterior circulation strokes will be enrolled. The main goal is to see if more people can live independently or return to their previous level of function 90 days later.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Albumin (a protein given intravenously)
What this could lead to
If it works, this could provide a new, widely available treatment to improve recovery after a severe stroke.
What could go wrong
This is a large Phase 3 trial, but albumin has not been proven effective for stroke before. There is a risk of side effects like fluid overload or allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,192 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age between 18 and 80 years; 2. Acute ischemic stroke with indications for endovascular treatment within 24 hours of onset; 3. 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; 4. National Institute of Health Stroke Scale (NIHSS) score \>=6; 5. Alberta Stroke Program Early CT Score (ASPECTS) \>=3 points; 6. Modified Rankin Scale (mRS) score ≤4 before onset of the disease; 7. Written informed consent provided by the patients or their legal relatives. Exclusion Criteria: 1. 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; 2. History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, thrombocytopenic diseases, etc; 3. Anticipated difficulty in completing endovascular treatment due to vascular tortuosity; 4. Known severe allergy (more severe than skin rash) to contrast agents uncontrolled by medications; 5. Pregnancy, breastfeeding; 6. An episode or exacerbation of congestive heart failure from any cause in the past 6 months; 7. History of heart valve disease complicated by congestive heart failure within the past 6 months; 8. Cardiac surgery with thoracotomy (eg. coronary artery bypass grafting or valve replacement surgery) within the past 6 months; 9. Acute myocardial infarction in the past 6 months; 10. Signs or symptoms of acute myocardial infarction upon admission, including electrocardiographic findings; 11. Elevated serum troponin concentration upon admission (\>0.1 μg/L) ; 12. Acute arrhythmia (including any tachycardia or bradycardia) with hemodynamic instability (systolic blood pressure \<100 mm Hg) upon admission; 13. Acute or chronic lung diseases requiring long-term or intermittent oxygen therapy; 14. 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; 15. Severe chronic anemia (hemoglobin \< 75 g/L); 16. Known recent or current serum creatinine exceeding 1.5 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) \< 60 mL/min; 17. Refractory hypertension that is difficult to control by medication (defined as systolic blood pressure \> 220 mmHg, or diastolic blood pressure \> 110 mmHg); 18. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is greater than 1.5 times the upper limit of the normal value. 19. History of albumin allergy or known allergy to albumin; 20. Patients with severe mental disorders or dementia who are unable to cooperate in completing informed consent and follow-up content; 21. The expected survival time is less than 90 days (such as comorbidity with malignant tumor or severe systemic diseases etc.); 22. Patients who have participated in other interventional clinical studies within 30 days before randomization or are currently participating in other interventional clinical studies. 23. The investigator believes that the subject has other conditions making it unsuitable for participating in this study.

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Conditions

The condition(s) this trial relates to.

ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute ischemic stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    56 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine

    RECRUITING

    Jinan, Shandong, 250011, China

  • Baoding No. 1 Central Hospital

    RECRUITING

    Baoding, Hebei, 071000, China

  • Bozhou People's Hospital

    RECRUITING

    Bozhou, Anhui, 236800, China

  • Cenxi People's Hospital

    RECRUITING

    Cenxi, Guangxi, 543200, China

  • Changde First People's Hospital

    RECRUITING

    Changde, Hunan, 415000, China

  • Daliuta Experimental Area Hospital of Shenmu City

    RECRUITING

    Shenmu, Shaanxi, 719315, China

  • Donggang Central Hospital

    RECRUITING

    Nanchong, Sichuan, 637300, China

  • Feicheng Hospital of Shandong Yiyang Health Group

    RECRUITING

    Feicheng, Shandong, 271608, China

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, Fujian, 350001, China

  • Gansu Provincial Hospital

    RECRUITING

    Lanzhou, Gansu, China

  • Guiyang Fourth People's Hospital

    RECRUITING

    Guiyang, Guizhou, 550002, China

  • Heyuan People's Hospital

    RECRUITING

    Heyuan, Guangdong, 517000, China

  • Huazhou People's Hospital

    RECRUITING

    Huazhou, Guangdong, 525100, China

  • Huiyang Sanhe Hospital

    RECRUITING

    Huizhou, Guangdong, 516211, China

  • Huize County People's Hospital

    RECRUITING

    Qujing, Yunnan, 654200, China

  • Jiamusi University Hongda Hospital

    RECRUITING

    Jiamusi, Heilongjiang, 154000, China

  • Jixi People's Hospital

    RECRUITING

    Jixi, Heilongjiang, China

  • Kailuan General Hospital Linxi Hospital

    RECRUITING

    Tangshan, Hebei, 063100, China

  • Laizhou People's Hospital

    RECRUITING

    Yantai, Shandong, China

  • Linyi People's Hospital

    RECRUITING

    Linyi, Shandong, 276000, China

  • Liuyang Jili Hospital

    RECRUITING

    Guankou, Hunan, 410300, China

  • Luoding People's Hospital

    RECRUITING

    Luoyang, Guangdong, 527200, China

  • Luoyang Central Hospital

    RECRUITING

    Luoyang, Henan, 471000, China

  • Ma'anshan People's Hospital

    RECRUITING

    Ma’anshan, Anhui, 243000, China

  • Meishan Second People's Hospital

    RECRUITING

    Meishan, Sichuan, 620500, China

  • Ningling County People's Hospital

    RECRUITING

    Shangqiu, Henan, China

  • PLA Joint Logistic Support Force 940th Hospital

    RECRUITING

    Lanzhou, Gansu, 730050, China

  • PLA Joint Logistic Support Force 970th Hospital

    RECRUITING

    Yantai, Shandong, 264000, China

  • People's Hospital of Bayingolin Mongolian Autonomous Prefecture

    RECRUITING

    Korla, Xinjiang, 841000, China

  • People's Hospital of Bortala Mongol Autonomous Prefecture

    RECRUITING

    Bole, Xinjiang, 833400, China

  • Pingdingshan Second People's Hospital

    RECRUITING

    Pingdingshan, Henan, 467000, China

  • Rizhao Hospital of Traditional Chinese Medicine

    RECRUITING

    Rizhao, Shandong, China

  • Sanshui Hospital of Zhujiang Hospital, Southern Medical University

    RECRUITING

    Foshan, Guangdong, 528100, China

  • Shanghai General Hospital Jiujuan Hospital

    RECRUITING

    Jiuquan, Gansu, China

  • Shenqiu County People's Hospital

    RECRUITING

    Zhoukou, Henan, 466300, China

  • Si County People's Hospital

    RECRUITING

    Suzhou, Anhui, China

  • Susong County Hospital of Traditional Chinese Medicine

    RECRUITING

    Anqing, Anhui, 246501, China

  • Taihe County Hospital of Traditional Chinese Medicine

    RECRUITING

    Fuyang, Anhui, China

  • Taihe Hospital, Hubei University of Medicine

    RECRUITING

    Shiyan, Hubei, 442000, China

  • The First Affiliated Hospital of Henan University of Chinese Medicine

    NOT_YET_RECRUITING

    Zhengzhou, Henan, China

  • The First Affiliated Hospital of Shaoyang University

    RECRUITING

    Shaoyang, Hunan, 422000, China

  • The First Affiliated Hospital of Xinxiang Medical University

    RECRUITING

    Weihui, Henan, China

  • Tianmen First People's Hospital

    RECRUITING

    Tianmen, Hubei, 431700, China

  • Wuhu Second People's Hospital

    RECRUITING

    Wuhu, Anhui, 241000, China

  • Wuwei People's Hospital

    RECRUITING

    Wuhu, Anhui, 238300, China

  • Xihua County People's Hospital

    RECRUITING

    Zhoukou, Henan, 466600, China

  • Xuanwu Hospital，Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100053, China

  • Xuzhou Cancer Hospital

    RECRUITING

    Xuzhou, Jiangsu, 221005, China

  • Yan'an University Xianyang Hospital

    RECRUITING

    Xianyang, Shaanxi, 712000, China

  • Yiyang Central Hospital

    RECRUITING

    Yiyang, Hunan, 413000, China

  • Yiyuan County People's Hospital

    RECRUITING

    Zibo, Shandong, 256100, China

  • Yuncheng Central Hospital

    RECRUITING

    Yuncheng, Shanxi, 044000, China

  • Zhangzhou Hospital

    RECRUITING

    Zhangzhou, Fujian, 363000, China

  • Zhengzhou Central Hospital Affiliated to Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450007, China

  • Zhongmou County People's Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Zhoukou Central Hospital

    RECRUITING

    Zhoukou, Henan, 466000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.