Clinical trial NCT05628896: Efficacy of a Preoperative Anaemia Clinic in Patients Undergoing Elective Abdominal Surgery
Official title: Efficacy of a Preoperative Anaemia Clinic in Patients Undergoing Elective Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia, Iron-Deficiency
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 764
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients scheduled for elective abdominal surgery diagnosed with iron deficiency anaemia who received a pre- or postoperative intravenous iron infusion. Patients receiving postoperative intravenous iron infusion will be excluded from the analysis.

Brief summary: Efficacy of a preoperative anaemia clinic in patients undergoing elective abdominal surgery diagnosed with iron deficieny anaemia

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess the possible change in hemoglobin (Hb) concentration in patients with iron deficiency anaemia undergoing intravenous iron infusion of MonoFer prior to abdominal surgery.
timeFrame: 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 outcomes:
measure: Assess the ideal time point for administration of preoperative intravenous iron infusion of MonoFer and the effect on Hb concentration
timeFrame: 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)).
Other outcomes:
measure: Investigate the effect of screening elective patients undergoing abdominal surgery preoperatively to prevent preoperative iron deficiency anaemia.
timeFrame: 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.
Locations:
city: Copenhagen
country: Denmark
facility: The Departments of Abdominal Surgery and the Department of Anesthesia, Centre for Cancer and Organ Disease at Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Eske Kvanner Aasvang, DMSci
role: STUDY_CHAIR
References: