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A prospective randomized controlled study of Roxastat in preoperative hemoglobin activation of elective cardiovascular surgery

A prospective randomized controlled study of Roxastat in preoperative hemoglobin activation of elective cardiovascular surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091367
Enrollment
Unknown
Registered
2024-10-28
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiovascular surgery

Interventions

Control group:intravenous infusion of erythropoietin 500IU/kg 24 hours before surgery
Test group:Roxastat 50mg orally every other day before surgery

Sponsors

Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 75 2. Cardiovascular surgery with cardiopulmonary bypass 3. Preoperative hemoglobin level (<130g/L for male, <120g/L for female) 4. Normal psychological state and agreed to participate in the study

Exclusion criteria

Exclusion criteria: 1. Age younger than 18 or elder than 75 2. Cardiovascular surgery without cardiopulmonary bypass 3. BMI10) 7. Emergent surgery 8. Patients who have already received Roxalstat or Recombinant human erythropoietin therapy 9. Coagulation disorders(Hereditary or acquired) 10. Allergic to any experimental medicine 11. Patients with malignant tumor, liver cirrhosis, thyroid dysfunction, respiratory failure and other diseases that significantly affect the clinical outcome 12. Patients who refused to participate in the trial or refused to sign an informed consent form

Design outcomes

Primary

MeasureTime frame
Preoperative hemoglobin level;Perioperative incidence of major cardiovascular adverse events;Incidence of postoperative acute kidney injury;

Secondary

MeasureTime frame
Amount of blood used during operation;Amount of blood used after surgery;Postoperative 30-day mortality;

Countries

China

Contacts

Public ContactZhou Qing

Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

zhouqing_penn@163.com+86 138 1401 3241

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026