Effect of Perioperative Roxadustat in Elective Lumbar Interbody Fusion Surgery.

Phase 3Active Not RecruitingNCT06772272

Second Affiliated Hospital, School of Medicine, Zhejiang University158 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

158

Conditions

Perioperative Anemia

Interventions

Roxadustat is an oral hypoxia-inducible factor prolyl-hydroxylase inhibitor (HIF-PHI) used to treat anemia. Participants in the Roxadustat group will receive 100mg of Roxadustat orally three times per week for three weeks (two weeks prior to surgery and one week post-surgery). The dosage may be adjusted based on hemoglobin levels during the perioperative period: if hemoglobin rises above 150g/L, the drug will be stopped; if hemoglobin increases by more than 20g/L from baseline but is still below 130g/L, the dosage will be reduced to 70mg; if hemoglobin drops by more than 20g/L from baseline, the dosage will be increased to 120mg.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Perioperative RBC transfusion requirement

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

Time frame: Discharge or within 4 weeks of hospitalization (whichever comes first)

Secondary Outcomes

Blood Transfusion Rate

The percentage of participants in each group requiring red blood cell transfusion during the perioperative period.

Time frame: Discharge or within 4 weeks of hospitalization (whichever comes first)

Volume of Blood Transfused

The total volume of red blood cells transfused in units per participant during the perioperative period.

Time frame: Discharge or within 4 weeks of hospitalization (whichever comes first)

Hemoglobin Levels at Different Time Points

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.

Time frame: Baseline, pre-surgery, during surgery, 1, 3, 5, and 28 days post-surgery, and at 1 month and 6 months follow-up.

Ferritin and Anemia-Related Blood Tests

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.

Time frame: Baseline, pre-surgery, 1, 3, 5, 28 days post-surgery.

Length of Hospital Stay

The total duration of hospitalization for each participant, measured in days.

Time frame: Discharge or within 4 weeks of hospitalization (whichever comes first)

Hospitalization Costs

The total cost of the hospital stay for each participant, including all treatments and care.

Time frame: Discharge or within 4 weeks of hospitalization (whichever comes first)

Thrombotic Events

Incidence of thrombotic events, including deep vein thrombosis, myocardial infarction, ischemic stroke, and pulmonary embolism.

Time frame: From admission to discharge (up to 28 days) and at follow-up visits at 1 and 6 months post-surgery.

Hyperkalemia

Occurrence of elevated potassium levels (hyperkalemia) during the perioperative period.