To measure the effect of intravenous ferric carboxymaltose treatment on exercise tolerance, microvascular perfusion and perioperative hemostasis in patients with mild iron deficiency anemia undergoing arterial vascular surgery.
ID
Source
Brief title
Condition
- Anaemias nonhaemolytic and marrow depression
- Vascular therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in exercise tolerance (submaximale bicycle test)
Secondary outcome
Microvascular perfusion (intravital microscopic imaging of the sublingual
microvasculature)
Perioperative hemostasis (blood samples)
Background summary
Perioperative anemia is common in cardiac and non-cardiac surgery and
associated with an increased risk of postoperative complications. Mild anemia
not only leads to a reduction in the oxygen-carrying capacity of blood, leading
to a suboptimal physical condition of the patient, but is also potentially
associated with changes in the microcirculatory perfusion and perioperative
hemostasis. In the present study we therefore aim to investigate whether
treatment of patients undergoing vascular surgery with mild iron deficiency
anemia using intravenous iron improves overall physical fitness,
microcirculation perfusion and perioperative haemostasis compared to untreated
patients.
Study objective
To measure the effect of intravenous ferric carboxymaltose treatment on
exercise tolerance, microvascular perfusion and perioperative hemostasis in
patients with mild iron deficiency anemia undergoing arterial vascular surgery.
Study design
Single-blind, randomized controlled, intervention study
Intervention
Ferinject or placebo injection
Study burden and risks
Exercise tolerance is tested non-invasively using a bicycle test, which has to
be performed three times by all patients (before intervention, before surgery,
and a month after surgery). Sublingual microcirculatory imaging is a
noninvasive measurement. A total of 56 ml of extra blood will be drawn by
venapuncture or from an existing intravascular catheter. The intravascular
catheter is part of routine clinical care in arterial vascular surgery, and
will therefore not add up to patient discomfort in the present study.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Adult subjects (age 18-85 years)
Elective vascular surgery
Type of anemia that can be treated by iron injections
Preoperative hemoglobin levels of 13 - 10 g/dL or 8.1 - 6.2 mmol/L in males and 12 - 10 g/dL or 7.5 - 6.2 mmol/L in females.
Informed consent
Exclusion criteria
Re-operation
Emergency operation
Pregnancy
Patients that are scheduled to receive any form of anemia treatment
Patients with a contraindication for receiving iron
Patients with COPD or asthma
Patients with severe renal failure or renal replacement therapy
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 | EUCTR2013-003417-17-NL |
| CCMO | NL45914.029.13 |