Clinical trial NCT06772272: Effect of Perioperative Roxadustat in Elective Lumbar Interbody Fusion Surgery.
Official title: Effect of Perioperative Roxadustat in Elective Lumbar Interbody Fusion Surgery: a Parallel-group, Open-label, Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Perioperative Anemia
Keywords: Anemia
Roxadustat
Transfusion
Surgery
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Perioperative RBC transfusion requirement
timeFrame: Discharge or within 4 weeks of hospitalization (whichever comes first)
Secondary outcomes:
measure: Blood Transfusion Rate
timeFrame: Discharge or within 4 weeks of hospitalization (whichever comes first)
measure: Volume of Blood Transfused
timeFrame: Discharge or within 4 weeks of hospitalization (whichever comes first)
measure: Hemoglobin Levels at Different Time Points
timeFrame: Baseline, pre-surgery, during surgery, 1, 3, 5, and 28 days post-surgery, and at 1 month and 6 months follow-up.
measure: Ferritin and Anemia-Related Blood Tests
timeFrame: Baseline, pre-surgery, 1, 3, 5, 28 days post-surgery.
measure: Length of Hospital Stay
timeFrame: Discharge or within 4 weeks of hospitalization (whichever comes first)
measure: Hospitalization Costs
timeFrame: Discharge or within 4 weeks of hospitalization (whichever comes first)
measure: Thrombotic Events
timeFrame: From admission to discharge (up to 28 days) and at follow-up visits at 1 and 6 months post-surgery.
measure: Hyperkalemia
timeFrame: From the start of medication until 3 days after the end of treatment.
measure: Metabolic Acidosis
timeFrame: From the start of medication until 3 days after the end of treatment.
measure: Neurological Side Effects (Dizziness, Drowsiness, Seizures)
timeFrame: From the start of medication until 3 days after the end of treatment.
measure: Gastrointestinal Side Effects
timeFrame: From the start of medication until 3 days after the end of treatment.
measure: Limb Edema
timeFrame: From the start of medication until 3 days after the end of treatment.
measure: Upper Respiratory Tract Infections
timeFrame: From the start of medication until 3 days after the end of treatment.
measure: Allergic Reactions
timeFrame: From the start of medication until 3 days after the end of treatment.
measure: Insomnia
timeFrame: From the start of medication until 3 days after the end of treatment.
measure: Acute Kidney Injury
timeFrame: From the start of surgery until hospital discharge or within 4 weeks post-surgery.
measure: Postoperative Infections
timeFrame: From the start of surgery until hospital discharge or within 4 weeks post-surgery.
measure: Mortality Rate
timeFrame: From the start of surgery until follow-up visits at 1 and 6 months post-surgery.
measure: MACE (Major Adverse Cardiovascular Events)
timeFrame: From the start of surgery until follow-up visits at 1 and 6 months post-surgery.
measure: Other New Adverse Reactions
timeFrame: From admission to discharge (up to 28 days) and at follow-up visits at 1 and 6 months post-surgery.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University, School of Medicine
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Min Yan, MD, PhD
role: STUDY_CHAIR
References: