Efficacy of a Preoperative Anaemia Clinic in Patients Undergoing Elective Abdominal Surgery

Study Overview
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Brief Summary
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Efficacy of a preoperative anaemia clinic in patients undergoing elective abdominal surgery diagnosed with iron deficieny anaemia

Detailed Description
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Objective: this study aims to investigate how preoperative intravenous iron treatment affects hemoglobin elevations in patients undergoing elective abdominal surgery diagnosed with iron deficiency anaemia and when treatment should be administrated for optimal effect. Methods: the study is a prospective, descriptive cohort study, where patients are included from a quality improvement project at The Departments of Abdominal Surgery and the Department of Anesthesia, Centre for Cancer and Organ Disease at Rigshospitalet in Denmark. Patients undergoing elective abdominal surgery will be screened for iron deficiency anaemia 1-4 weeks prior to surgery and patients diagnosed with iron deficiency anaemia will be included. Intravenous iron infusion will be administrated preoperatively and Hb will be measured 1-2 days prior to surgery or on day of surgery. The preparation used is ferric derisomaltose (MonoFer, Pharmacosmos A/S, Holbæk, Denmark) with a max single iron dose of 20 mg/kg. The dose administrated is calculated using patient bodyweight and Hb value and administered ≥30 minutes followed by 30 minutes observation including monitoring with 3-lead ECG and pulsoximitri. Study results will be sought to be published in an international peer-reviewed journal.

Official Title
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Efficacy of a Preoperative Anaemia Clinic in Patients Undergoing Elective Abdominal Surgery

Conditions
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Anemia, Iron-Deficiency

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients diagnosed with preoperative iron deficiency anaemia All patients receiving preoperative or postoperative intravenous iron infusion Patients undergoing elective abdominal surgery Exclusion Criteria: Patients missing Hb values after intravenous iron infusion prior to surgery Patients undergoing acute abdominal surgery
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the possible change in hemoglobin (Hb) concentration in patients with iron deficiency anaemia undergoing intravenous iron infusion of MonoFer prior to abdominal surgery. | Preoperative anaemia is defined as: Hb <8,1 mM for men Hb <7,5 mM for women Iron deficiency was defined as TSAT <20%. Iron deficiency anaemia was defined as TSAT <20% with concurrent anaemia. Paired Student's t-test will be performed to analyze whether intravenous iron infusion prior to surgery results in a significant increased Hb level at the day of surgery in patients with preoperative iron deficiency anaemia. In case data is not normally distributed, data will be analyzed using Wilcoxon signed rank test. | Hb values [mM] from blood samples taken before the preliminary examination and 1-2 days prior to surgery in patients receiving intravenous iron infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the ideal time point for administration of preoperative intravenous iron infusion of MonoFer and the effect on Hb concentration | To assess if there is a significant difference in patients receiving iron infusion >2 weeks and <2 weeks preoperatively an Unpaired Students T-test will be performed. A comparison of delta Hb values (±SD) will furthermore be investigated. To evaluate whether there is an ideal day of preoperative administration, linear regression and correlation analysis will analyze the correlation between delta Hb values and days between administrated treatment and day of surgery. Lastly a multiple linear regression will be performed to analyze potential interaction between delta Hb and: Age Severity of anaemia Preoperative chemotherapy | Hb values [mM] from blood samples taken before the preliminary examination and 1-2 days prior to surgery in patients receiving intravenous iron infusion. Number of days between infusion of intravenous MonoFer and day of surgery (up to 3 months)). |