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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:
Researchers will compare Roxadustat to standard clinical care without Roxadustat to determine its effectiveness and safety.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roxadustat | Experimental | 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. |
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| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roxadustat | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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):
| Discharge or within 4 weeks of hospitalization (whichever comes first) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Transfusion Rate | The percentage of participants in each group requiring red blood cell transfusion during the perioperative period. | Discharge or within 4 weeks of hospitalization (whichever comes first) |
| Volume of Blood Transfused |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min Yan, MD, PhD | Zhejiang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital of Zhejiang University, School of Medicine | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C584543 | roxadustat |
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The total volume of red blood cells transfused in units per participant during the perioperative period.
| 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. | 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. | 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. | 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. | 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. | 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. | From the start of medication until 3 days after the end of treatment. |
| Metabolic Acidosis | Incidence of metabolic acidosis as measured by blood gas analysis. | From the start of medication until 3 days after the end of treatment. |
| Neurological Side Effects (Dizziness, Drowsiness, Seizures) | Occurrence of neurological side effects, including dizziness, drowsiness, or seizures, reported by participants or physicians. | From the start of medication until 3 days after the end of treatment. |
| Gastrointestinal Side Effects | Incidence of gastrointestinal side effects, including nausea, vomiting, indigestion, and diarrhea. | From the start of medication until 3 days after the end of treatment. |
| Limb Edema | Occurrence of edema in the limbs during the medication period. | From the start of medication until 3 days after the end of treatment. |
| Upper Respiratory Tract Infections | Incidence of upper respiratory tract infections during the medication period. | From the start of medication until 3 days after the end of treatment. |
| Allergic Reactions | Occurrence of allergic reactions to the medication or other substances during the medication period. | From the start of medication until 3 days after the end of treatment. |
| Insomnia | Incidence of insomnia reported by participants during the medication period. | From the start of medication until 3 days after the end of treatment. |
| Acute Kidney Injury | Incidence of acute kidney injury as defined by KDIGO criteria. | From the start of surgery until hospital discharge or within 4 weeks post-surgery. |
| Postoperative Infections | Incidence of infections following surgery, including sepsis and pneumonia. | From the start of surgery until hospital discharge or within 4 weeks post-surgery. |
| Mortality Rate | All-cause mortality during the perioperative period and follow-up. | From the start of surgery until follow-up visits at 1 and 6 months post-surgery. |
| MACE (Major Adverse Cardiovascular Events) | Incidence of MACE, including all-cause mortality, non-fatal myocardial infarction, and non-fatal stroke. | From the start of surgery until follow-up visits at 1 and 6 months post-surgery. |
| Other New Adverse Reactions | Any other newly reported adverse reactions that were not pre-specified but occurred during the perioperative period. | From admission to discharge (up to 28 days) and at follow-up visits at 1 and 6 months post-surgery. |