|- candidate number||15454|
|- NTR Number||NTR4185|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-sep-2013|
|- Secondary IDs||13/377 Metc|
|- Public Title||Effect of preoperative intravenous administration of iron in patients with mild anemia undergoing arterial vascular surgery.|
|- Scientific Title||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.|
|- hypothesis||Treatment with intravenous ferric carboxymaltose improves exercise tolerance, microvascular perfusion, perioperative hemostasis and tissue oxygenation in patients with mild anemia undergoing vascular surgery.|
|- Healt Condition(s) or Problem(s) studied||Anemia, Iron deficiency , Vascular surgery, Hemostasis|
|- 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
- 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
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2013|
|- planned closingdate|
|- Target number of participants||40|
|- 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 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.|
|- 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?
|- Timepoints||- 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.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. Christa Boer|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Christa Boer|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|- Brief 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.|
|- Main changes (audit trail)|
|- RECORD||24-sep-2013 - 7-jan-2016|