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postoperative intravenous iron injections (Venofer) vs. control in total hip and knee arthroplasty

postoperative intravenous iron injections (Venofer) vs. control in total hip and knee arthroplasty - postoperative venofer in total hip and knee arthroplasty

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30673
Enrollment
126
Registered
2007-01-26
Start date
2007-08-01
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

iron defecient anemia

Interventions

Patients in the study group will receive 300 mg intravenous iron sucrose (3 ampuls à 5 ml Venofer) on day 0 and 1 postoperative.

Sponsors

Atrium Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients sceduled for elective total hip or knee arthroplasty with preoperative hemoglobin level above 6.8 mmol/l.

Exclusion criteria

Exclusion criteria: Patients with already threated anemia, patients with hemosiderosis, any active infection, current malignancy, uncontrolled hypertension, operated in 3 weeks before randomisation, having blood transfusions in 3 weeks before randomisation, known hypersensitivity to Venofer or one of its components.

Design outcomes

Primary

MeasureTime frame
Change in perioperative parameters of iron metabolism and erythroipoiesis. The main parameter is ret-y which indicates the process of reticylocyte hemoglobinisation.

Secondary

MeasureTime frame
Other parameters are ferritin, transferrin, transferrin receptor and ZPP. Another secundary outcome is perioperative hemoglobin level and amount of allogeneic blood transfusions in both groups.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)