MedTrace Logo

Effect of Perioperative Roxadustat in Elective Lumbar Interbody Fusion Surgery.

NCT06772272 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2025-01-13

No results posted yet for this study

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.

Conditions

  • Perioperative Anemia

Interventions

DRUG

Roxadustat

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.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Min Yan, MD, PhD · Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-10
Primary Completion
2026-11-10
Completion
2027-05-10

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06772272 on ClinicalTrials.gov