Evaluate iron metabolism, erythropoiesis and hemoblobin level periooperative in patients treated with postoperative intravenous iron injections compared to controls.
ID
Source
Brief title
Condition
- Haematological disorders NEC
- Iron and trace metal metabolism disorders
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in perioperative parameters of iron metabolism and erythroipoiesis. The
main parameter is ret-y which indicates the process of reticylocyte
hemoglobinisation.
Secondary outcome
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.
Background summary
Prosthetic surgery is associated with considerable blood loss and blood
transfusions are frequently necessary. Blood transfusion is associated with a
number of risks and complications, including allergic reactions, transmission
of infectious agents, and immunomodulatory effects. These potentials risks of
allogeneic blood transfusions have lead to a more restrictive transfusion
policy.
Postoperative systemic inflammation is probably the factor which impaired the
effect of oral iron therapy. Parenteral iron may act by treating a functional
iron deficiency and/or by increasing endogenous erythropoietin synthesis.
Faster reversibility of anaemia following iron injection improves quality of
the postoperative recover. The effect of venofer on parameters of iron
metabolism is unclear.
Study objective
Evaluate iron metabolism, erythropoiesis and hemoblobin level periooperative in
patients treated with postoperative intravenous iron injections compared to
controls.
Study design
The study is a prospective randomised clinical trial. All patients will be
randomly allocated into a Venofer group, or a control group.
Intervention
Patients in the study group will receive 300 mg intravenous iron sucrose (3
ampuls à 5 ml Venofer) on day 0 and 1 postoperative.
Study burden and risks
Safety of intravenous iron injections has already been proven in the past.
Therefore the risks is minimal to develop adverse events or undesired reactions
by using Venofer.
The burden is also minimal. The collection of extra blood mainly occurs
simultaneously with routine venipunctures.
henry dunantstraat 5
6419 pc heerlen
Nederland
henry dunantstraat 5
6419 pc heerlen
Nederland
Listed location countries
Age
Inclusion criteria
Patients sceduled for elective total hip or knee arthroplasty with preoperative hemoglobin level above 6.8 mmol/l.
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-004293-27-NL |
| CCMO | NL13940.096.07 |