Rice-derived albumin for low albumin after liver surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm, exploratory trial evaluating the safety and efficacy of OsrHSA in patients who develop hypoalbuminemia after hepatectomy. Participants will receive daily intravenous infusions of OsrHSA at 20 g per day. The study aims to determine whether OsrHSA can raise serum albumin levels and improve clinical outcomes without undue safety risks. Prior data in cirrhosis suggest non-inferiority to plasma-derived albumin, but this trial focuses on the postoperative setting. Enrollment targets are small and participants will be adults up to 80 years old at Tongji Hospital in Wuhan, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Able to understand and willing to sign the informed consent form.
* Male or female; age ≥18 years and ≤80 years.
* Planned for or has undergone hepatectomy.
* Developed postoperative hypoalbuminemia, defined as serum albumin ≤30 g/L .

Exclusion Criteria:

* Known hypersensitivity to the active ingredient or any excipient of the investigational drug
* Complicated with any of the following diseases or conditions: severe renal disease requiring hemodialysis, active upper gastrointestinal bleeding, hepatic encephalopathy Grade III or IV.
* Pregnant or lactating women.
* HIV positive.
* Heart failure classified as Stage C or D according to ACCF/AHA criteria.
* History of organ transplantation.
* Mental status that prevents the participant from understanding the nature, scope, and consequences of the study.
* Any clinical condition that the investigator considers makes the trial participant unsuitable for participation in the trial.

Where it's running

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Qi Cheng, M.D.
• Email: chengqi@hust.edu.cn
• Phone: 13871459541

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.