Effect of Perioperative Roxadustat in Elective Lumbar Interbody Fusion Surgery.

Phase 3

Active, not recruiting

• Conditions: Perioperative Anemia
• Interventions: Drug: Roxadustat

• Registration Number: NCT06772272
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-22
• Study Start: 2024-11-10
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Primary Completion: 2026-11-10
• Study Completion: 2027-05-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 158

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Roxadustat	Roxadustat	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.

Primary Outcome Measures

Name	Time	Method
Perioperative RBC transfusion requirement	Discharge or within 4 weeks of hospitalization (whichever comes first)	The incidence of the composite outcome of perioperative transfusion requirement (defined as the occurrence of one or more of the following events): * Red blood cell transfusion; * Perioperative lowest hemoglobin level below 80 g/L

Secondary Outcome Measures

Name	Time	Method
Blood Transfusion Rate	Discharge or within 4 weeks of hospitalization (whichever comes first)	The percentage of participants in each group requiring red blood cell transfusion during the perioperative period.
Volume of Blood Transfused	Discharge or within 4 weeks of hospitalization (whichever comes first)	The total volume of red blood cells transfused in units per participant during the perioperative period.
Hemoglobin Levels at Different Time Points	Baseline, pre-surgery, during surgery, 1, 3, 5, and 28 days post-surgery, and at 1 month and 6 months follow-up.	Hemoglobin levels will be measured at key time points to assess changes, including: at baseline (enrollment), pre-surgery, during surgery, at 1, 3, 5, 28 days post-surgery, and at 1 month and 6 months follow-up visits to monitor longer-term effects.
Thrombotic Events	From admission to discharge (up to 28 days) and at follow-up visits at 1 and 6 months post-surgery.	Incidence of thrombotic events, including deep vein thrombosis, myocardial infarction, ischemic stroke, and pulmonary embolism.
Hyperkalemia	From the start of medication until 3 days after the end of treatment.	Occurrence of elevated potassium levels (hyperkalemia) during the perioperative period.
Ferritin and Anemia-Related Blood Tests	Baseline, pre-surgery, 1, 3, 5, 28 days post-surgery.	Levels of ferritin and other biomarkers related to anemia will be measured, including iron, transferrin, and vitamin B12, to assess the impact of Roxadustat on anemia.
Length of Hospital Stay	Discharge or within 4 weeks of hospitalization (whichever comes first)	The total duration of hospitalization for each participant, measured in days.
Hospitalization Costs	Discharge or within 4 weeks of hospitalization (whichever comes first)	The total cost of the hospital stay for each participant, including all treatments and care.
Metabolic Acidosis	From the start of medication until 3 days after the end of treatment.	Incidence of metabolic acidosis as measured by blood gas analysis.
Neurological Side Effects (Dizziness, Drowsiness, Seizures)	From the start of medication until 3 days after the end of treatment.	Occurrence of neurological side effects, including dizziness, drowsiness, or seizures, reported by participants or physicians.
Gastrointestinal Side Effects	From the start of medication until 3 days after the end of treatment.	Incidence of gastrointestinal side effects, including nausea, vomiting, indigestion, and diarrhea.
Limb Edema	From the start of medication until 3 days after the end of treatment.	Occurrence of edema in the limbs during the medication period.
Upper Respiratory Tract Infections	From the start of medication until 3 days after the end of treatment.	Incidence of upper respiratory tract infections during the medication period.
Allergic Reactions	From the start of medication until 3 days after the end of treatment.	Occurrence of allergic reactions to the medication or other substances during the medication period.
Insomnia	From the start of medication until 3 days after the end of treatment.	Incidence of insomnia reported by participants during the medication period.
Acute Kidney Injury	From the start of surgery until hospital discharge or within 4 weeks post-surgery.	Incidence of acute kidney injury as defined by KDIGO criteria.
Postoperative Infections	From the start of surgery until hospital discharge or within 4 weeks post-surgery.	Incidence of infections following surgery, including sepsis and pneumonia.
Mortality Rate	From the start of surgery until follow-up visits at 1 and 6 months post-surgery.	All-cause mortality during the perioperative period and follow-up.
MACE (Major Adverse Cardiovascular Events)	From the start of surgery until follow-up visits at 1 and 6 months post-surgery.	Incidence of MACE, including all-cause mortality, non-fatal myocardial infarction, and non-fatal stroke.
Other New Adverse Reactions	From admission to discharge (up to 28 days) and at follow-up visits at 1 and 6 months post-surgery.	Any other newly reported adverse reactions that were not pre-specified but occurred during the perioperative period.

Trial Locations

Locations (1)

Second Affiliated Hospital of Zhejiang University, School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China