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

NCT05628896 | Completed

• 1 other identifier: RH-2043-KB1
• Study Type: observational
• Target: 764
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anemia, Iron-Deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  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 (1)

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

  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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All patients diagnosed with preoperative iron deficiency anaemia
• All patients receiving preoperative or postoperative intravenous iron infusion
• Patients undergoing elective abdominal surgery

You may not qualify if:

• Patients missing Hb values after intravenous iron infusion prior to surgery
• Patients undergoing acute abdominal surgery

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

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

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

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

Study Officials

• Eske Kvanner Aasvang, DMSci

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 29, 2022
• Study Start: June 1, 2020
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: February 28, 2025

Record last verified: 2023-03

Locations

DK (1)