Effect of Perioperative Roxadustat in Elective Lumbar Interbody Fusion Surgery. (PRELIFS)

Zhejiang University

Status and phase: Active, not recruiting; Phase 3

Conditions: Perioperative Anemia

Treatments: Drug: Roxadustat

Study type: Interventional

Funder types: Other

Identifiers

NCT06772272

2024-0037

Details and patient eligibility

About

The goal of this clinical trial is to assess whether Roxadustat can reduce perioperative blood transfusions in patients with anemia undergoing elective lumbar interbody fusion surgery. It will also evaluate the safety of Roxadustat in this context. The main questions it aims to answer are:

• Does Roxadustat reduce the need for perioperative red blood cell transfusions?
• Is Roxadustat safe for use in patients during the perioperative period?

Researchers will compare Roxadustat to standard clinical care without Roxadustat to determine its effectiveness and safety.

Participants will:

• Take Roxadustat orally three times a week for three weeks (two weeks before surgery and one week post-surgery).
• Undergo regular blood tests and follow-up monitoring during the hospital stay and up to 6 months after surgery.

Enrollment: 158 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years, no upper age limit, sex unrestricted.
• Scheduled for elective lumbar interbody fusion surgery.
• Diagnosed with anemia (Hemoglobin levels: male <130g/L, female <120g/L).
• Willing to participate and able to voluntarily sign an informed consent form.

Exclusion criteria

• Patients admitted on an emergency basis.
• Patients with moderate to severe anemia (Hemoglobin levels <90g/L).
• Patients already enrolled in another clinical study.
• Patients unable to comply with the study protocol due to cognitive or language barriers.
• Pregnant or breastfeeding women.
• Patients who have already received erythropoiesis-stimulating agents, iron supplements, or other treatments to increase hemoglobin levels.
• Patients with severe infections.
• Patients with a history of acute coronary syndrome, heart failure, or cerebrovascular events within the last 3 months.
• Any other medical condition that may pose a safety risk, confound efficacy or safety evaluations, or interfere with study participation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 2 patient groups

Roxadustat

Experimental group

Description:

Participants in this group will receive Roxadustat, administered orally at a dose of 100mg three times per week for a total of three weeks. This treatment will begin two weeks prior to the scheduled lumbar interbody fusion surgery and continue for one week postoperatively. The aim is to evaluate whether Roxadustat reduces perioperative blood transfusion requirements and assess its safety during the perioperative period.

Treatment:

Drug: Roxadustat

Control

No Intervention group

Description:

Participants in this group will receive standard clinical care according to the hospital's guidelines without the administration of Roxadustat. This group serves as a comparator to evaluate the effectiveness of Roxadustat in reducing perioperative blood transfusions during elective lumbar interbody fusion surgery.