Efficacy of a Preoperative Anaemia Clin… | Clinical Trial

Key information

Conditions

Anemia, Iron-Deficiency Anemia Anemia, Hypochromic Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

The Departments of Abdominal Surgery and the Department of Anesthesia, Centre for Cancer and Organ Disease at Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Assess the possible change in hemoglobin (Hb) concentration in patients with iron deficiency anaemia undergoing intravenous iron infusion of MonoFer prior to abdominal surgery.

Time frame: Hb values [mM] from blood samples taken before the preliminary examination and 1-2 days prior to surgery in patients receiving intravenous iron infusion
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.

Secondary outcomes

Assess the ideal time point for administration of preoperative intravenous iron infusion of MonoFer and the effect on Hb concentration

Time frame: 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)).
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

Other outcomes

Investigate the effect of screening elective patients undergoing abdominal surgery preoperatively to prevent preoperative iron deficiency anaemia.

Time frame: Number of patients undergoing elective abdominal surgery from June 2020 - August 2022 with iron deficiency anaemia who had not been screened and administrated preoperative intravenous iron infusion.

Number of patients with iron deficiency anaemia on day of surgery who had been screened and administrated intravenous iron infusion and who had not will be calculated and compared (number and percentages).

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Nov 29, 2022
Registry last updated: Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed