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Efficacy and safety of ultra-short-term treatment of patients with perioperative anemia undergoing primary total hip or total knee arthroplasty: a prospective randomised trial

Efficacy and safety of ultra-short-term treatment of patients with perioperative anemia undergoing primary total hip or total knee arthroplasty: a prospective randomised trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104525
Enrollment
Unknown
Registered
2025-06-18
Start date
2025-06-19
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Hip and knee joint disease

Interventions

The group A:Primary THA/TKA patients with preoperative anemia receive a single ultra-short-term anemia regimen on the day of admission (ferric carboxymaltose 20 mg/kg up to 1,000 mg IV, EPO 40,000 U (
The group B:Primary THA/TKA patients with preoperative anemia received placebo on the day of admission (250 ml of 5% dextrose sodium chloride solution (administered intravenously over 30 minutes by op
The group C:Primary THA/TKA patients with new-onset postoperative anemia receive a single ultra-short-term anemia regimen on the postoperative day 1 (ferric carboxymaltose 20 mg/kg up to 1,000 mg IV,
The group D:Primary THA/TKA patients with new-onset postoperative anemia received placebo on the postoperative day 1 (250 ml of 5% dextrose sodium chloride solution (administered intravenously over 30

Sponsors

Department of Orthopaedic surgery, West China Hospital, Sichuan University.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Included patients were between 18-80 years of age, proposed for primary unilateral THA/TKA for end-stage hip/knee arthropathy, with a combination of mild preoperative anemia (90 < Hb < 130 in men and 90 < Hb < 120 in women) as well as new-onset postoperative anemia (90 < Hb < 130 in men and 90 < Hb < 120 in women)

Exclusion criteria

Exclusion criteria: 1. complex primary surgery, revision surgery, tumor resection, etc.; 2. known allergy to rhEPO, iron, vitamin B12, or folic acid, 3. use of spinal anesthesia; 4. history of hematopoietic or bleeding disorders; (v) history of deep vein thrombosis (DVT) or pulmonary embolism (PE) on anticoagulant therapy (warfarin or heparin); 5. receiving iron and/or rhEPO within 3 months prior to admission, 6. preoperative hepatic or renal insufficiency; 7. severe cardiac and/or cerebrovascular comorbidities; 8. those who refused to participate in the study; and 9. those who combined with intractable anemia and poor recovery from systemic therapy

Design outcomes

Primary

MeasureTime frame
Hemoglobin level;Blood loss volume;The rate of allogeneic blood transfusion(ABT);Reticulocyte level;

Secondary

MeasureTime frame
The total amount of red blood cells lost;The incidence of cardiovascular and cerebrovascular complications during the perioperative period;The incidence of venous thromboembolism;adverse reactions related to drugs;Incidence of postoperative complications ;Harris Hip Score and Hospital for Special Surgery Knee Score;range of motion of hip and knee;Length of stay;Patient satisfaction;

Countries

China

Contacts

Public ContactZongke Zhou

Department of Orthopaedic surgery, West China Hospital, Sichuan University.

zhouzongke@scu.edu.cn+86 189 8060 1028

Outcome results

None listed

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