Primary aim:- What is the increase in hemoglobin concentration between epoetin alpha injection number three and four in patients awaiting orthopedic surgery?Secondary aim:- What is de increase in hemoglobin concentration between epoetin alpha…
ID
Source
Brief title
Condition
- Red blood cell disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the increase in Hb concentration after each epoetin
alpha injection on day -1 versus day -7 before surgery.
Secondary outcome
Secundary study parameters are the increase in Hb concentration after each
epoetin alpha injection on day -14, day -7 and on the day of surgery (day 0).
Baseline Hb concentration will be measured on day -21, at the start of the
treatment with epoetin alpha.
Safety will be assessed by registration of adverse events, such as nausea and
influence-like symptoms.
Adherence to the prescribed treatment (epoetin alpha plus iron) will be
assessed by the Medication Adherence Report Scale (MARS) questionnaire.
Background summary
Elective orthopedic surgery, such as total hip and knee replacement, is
associated with severe blood loss. As a consequence, without additional blood
saving techniques, approximately half of the patients need a blood transfusion
after orthopedic surgery.
To prevent unnecessary blood transfusion several measures are advised. To
improve the preoperative status of the patient iron and epoetin alpha are
used.
In standard dose, patients receive 600 IU/kg subcutaneously once weekly for
three weeks before surgery and on the day of surgery in combination with iron.
In practice, this dosage is fixed at a weekly dose of 40,000 IU.
Nevertheless, recent studies showed conflicting results about the
cost-effectiveness of epoetin alpha. As no consensus exists which price is
reasonable for the prevention of a blood transfusion, the cost-effectiveness of
pre-operative epoetin alpha, is questioned.
It could be hypothesized that a more personalized dosing schedule might
increase the cost effectiveness of epoetin alpha and also decrease the
incidence of dose depended side effects.
The effect of the number of erythropoietin injections on Hb level of mildly
anemic patients eligible for large orthopedic surgery has not been described
yet. The aim of this study is therefore to assess the effect of the number of
erythropoietin injections on the Hb level of anemic patients awaiting
orthopedic surgery. The results of the study will provide a better
understanding about the dose-response relationship of erythropoietin on the Hb
level of a mildly anemic patient. It will also provide a better understanding
about the increase of the Hb level at different baseline Hb levels.
Study objective
Primary aim:
- What is the increase in hemoglobin concentration between epoetin alpha
injection number three and four in patients awaiting orthopedic surgery?
Secondary aim:
- What is de increase in hemoglobin concentration between epoetin alpha
injection number one to three in patients awaiting orthopedic surgery?
- - What is de increase in hemoglobin concentration between epoetin alpha
injection number four and the day of surgery in patients awaiting orthopedic
surgery?
- Is the increase in hemoglobin concentration associated with the hemoglobin
concentration at baseline?
- What proportion of patients reaches maximal advised hemoglobin concentration
of 15 g/dL after each subsequent injection?
- Description of side effects
Study design
This study is an observational prospective cohort study.
No control group will be set.
Study burden and risks
The extent of burden en risks are negligible. The only effect of the study on
the participant is the execution of five fingertips and filling in one
questionaire.
Hengstdal 3
Ubbergen 6574NA
NL
Hengstdal 3
Ubbergen 6574NA
NL
Listed location countries
Age
Inclusion criteria
Indication for treatment with epoetin alpha according to current guidelines and the opinion of the anaesthesiologists. Epoetin alpha is prescribed to patients with a preoperative Hb level between 10.0 * 13.0 g/dL, scheduled for elective orthopedic surgery with an expected blood loss of 900-1800 mL.
Exclusion criteria
* Any contra-indication for the use of epoetin alpha (hypersensitivity to epoetin alpha or any component of the formulation, uncontrolled hypertension, pure red cell aplasia due to epoetin alpha)
* Myocardial infarction or cerebral vascular accident within 6 months before inclusion
* Serious coronary disease
* Sickle cell anemia
* Pregnancy or lactation
* Existing use of iron supplementation
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 |
|---|---|
| CCMO | NL58460.091.16 |