Effect of preoperative intravenous administration of iron in patients with mild anemia undergoing arterial vascular surgery.

Changes in microvascular perfusion, exercise tolerance, perioperative hemostasis and tissue oxygenation after treatment with intravenous iron of patients with mild anemia undergoing arterial vascular surgery.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28479

Enrollment

Registered

2013-09-24

Start date

2013-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 w

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Does ferric carboxymaltose treatment improve exercise tolerance in patients with mild iron deficiency anemia undergoing vascular surgery?	—

Secondary

Measure	Time frame
- 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?	—

Measure

Time frame

- 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?

—

Contacts

Public ContactChrista Boer

VU University Medical Center, Department of Anesthesiology

c.boer@vumc.nl+31 (0)20 4443830

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)