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ID
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Brief title
Health condition
Mild anemia leads to suboptimal physical conditions of the patient and is potentially associated with changes in perioperative hemostasis and microcirculatory perfusion.
Furthermore, preoperative iron deficiency anemia is associated with an increased risk of postoperative mortality and morbidity in patients undergoing major (non-)cardiac surgery.
It was also shown that the preoperative administration of iron combined with erythropoietin in anaemic patients undergoing valve replacement reduced postoperative morbidity and mortality.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Does ferric carboxymaltose treatment improve exercise tolerance in patients with mild iron deficiency anemia undergoing vascular surgery?
Secondary outcome
- Does ferric carboxymaltose treatment improve microvascular perfusion in patients with mild iron deficiency anemia undergoing vascular surgery?
-- Does ferric carboxymaltose treatment improve perioperative hemostasis in patients with mild iron deficiency anemia undergoing vascular surgery?
- Does ferric carboxymaltose treatment improve tissue oxygenation in patients with mild iron deficiency anemia undergoing vascular surgery?
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 anemia using intravenous iron improves overall physical fitness, microcirculation perfusion and perioperative hemostasis compared to untreated patients.
Study objective
Treatment with intravenous ferric carboxymaltose improves exercise tolerance, microvascular perfusion, perioperative hemostasis and tissue oxygenation in patients with mild anemia undergoing vascular surgery.
Study design
- Bike ergometry and NIRS (tissue oxygenation) :2x: Before therapy, before surgery
- Microcirculation:7x: Microvascular perfusion will be measured before the study intervention, the day before surgery, at the beginning and end of surgery and at three time points after surgery (24 hours, 48 hours and one month following surgery).
- Blood sampling:7x: Blood will be drawn before the study intervention, before surgery, after anesthesia induction, at the end of surgery and at three time points after surgery (24 hours, 48 hours and one month following surgery (7 x 8 ml = 56 ml). During and after surgery, blood will be drawn from an existing intravascular catheter.
Intervention
Ferric carboxymaltose group: Maximum dosage per week: 1000 mg bolus ferric carboxymaltose in 15 minutes. Body weight < 70 kg: 1 bolus of 1000 mg (20 ml). Body weight ¡Ý 70 kg 1 bolus of 1000 mg, one week later 1 bolus of 500 mg (10 ml).
Placebo group: In the placebo group we will administer saline instead of ferric carboxymaltose. Body weight < 70 kg: 1 bolus of 20 ml saline. Body weight ¡Ý 70 kg: 1 bolus of 20 ml, one week later 1 bolus of 10 ml.
Christa Boer
De Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4443830
c.boer@vumc.nl
Christa Boer
De Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4443830
c.boer@vumc.nl
Inclusion criteria
- Adult subjects (age 18-85 years)
- Elective vascular surgery
- Iron deficiency
- 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
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In other registers
Register | ID |
---|---|
NTR-new | NL3971 |
NTR-old | NTR4185 |
Other | Metc : 13/377 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |