In this research we will investigate if i.v. iron therapy can become a method of blood saving therapy for orthopedic surgery and can replace erytropoietin.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
ijzergebreks anemie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
a. Is it possible that 1 gr i,v, iorn therapy may reduce the need for Epo with
75%
b. May 1 gr i,v, iron therapy reduce the amount of allogeneci bllood
transfusions comparable with Epo therapy
Secondary outcome
a. is this i.v. iron therapy also efficient for patients with anemia other than
iron deficiency
b. is infusion of i.v. iron policlinically safe?
c. cost reductions caused by introduction of i.v. iron therapy
d. hospital stay, time neede for revalidation, measurement of quality of life.
.
Background summary
efficacy of erytropoietin is less in case of iron depletion . Momentarily no
iron state is investigated before Epo-therapy. Not much is known about the
possibility to use intravenous iron therapy as a blood saving technique.
Theusinger treated 20 orthopedic patients with 900 mg i.v. iron in 10 days
divided over 4 weeks. Hij archieved a rise of 1 gr/dl hemoglobinlevel. He used
the old type of intravenous iron. These drug gave a lot of adverse reactions.
Infusion took 4-5 hours and could only be given after a test dose. With the new
i.v. drugs the total dose can be given in 15-30 min. This makes i.v. iron
therapy as potential method of blood saving tehrapies.
Study objective
In this research we will investigate if i.v. iron therapy can become a method
of blood saving therapy for orthopedic surgery and can replace erytropoietin.
Study design
Investigated are patients planned for a total hip or total knee replacement
operaton. Patients with a Hb * 8,1 mmol/l, will be included. Patients will
receive 1 gr i.v. iron on the day care 2 weeks before the operation. They will
be informed a few weeks before the visit. Patients in the Epo group will
receive 5 injections of epo (40.000 IE per injection. Before the 5th injection
Hb will be controlled. If Hb-level is > 9,1 mmol/l no injection will be given.
Study burden and risks
i.v.iron therapy takes 1 hour on day care. 4 x extra blood investigations. this
will be done by nurses of the transmuraal team at home. 3 x questionnaires,
patient diary
albert schweitzerplaats 25 3300 ak Dordrecht
Dordrecht 3300 AK
NL
albert schweitzerplaats 25 3300 ak Dordrecht
Dordrecht 3300 AK
NL
Listed location countries
Age
Inclusion criteria
- All patients planned for orthopedic surgery older than 18 years and planned for elective prothesis of hip or knee or revision.
Exclusion criteria
all patients who wish not to receive blood transfusions,
incontrolled hypertension
patients planned for preoperative autologous donoation
severe cardiac compromised patients
recent myocardial infacrction of CVA
patients with oncological processes except cured malginancy or skin cancer
pregnancy
onpossible to give prophylactic anticoagulant
allergy Epo
infected wound, infected prothesis
relative: epileptic, liver insufficiency, predisposition DVT
chronic bacteral infection
inflammatoir colon disease
serious asthma
serious allergy
serological doagnosed reuma
pregnancy
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
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-000230-11-NL |
| CCMO | NL35394.101.11 |
| OMON | NL-OMON22057 |