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

Anemia, Iron-Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05628896
• Other study ID #: RH-2043-KB1
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: January 1, 2025

Study information

• Verified date: March 2023
• Source: Rigshospitalet, Denmark
• Contact: Eske K. Aasvang, DMSci
• Phone: +45 26232076
• Email: eske.kvanner.aasvang.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency

Locations

Country	Name	City	State
Denmark	The Departments of Abdominal Surgery and the Department of Anesthesia, Centre for Cancer and Organ Disease at Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Investigate the effect of screening elective patients undergoing abdominal surgery preoperatively to prevent preoperative iron deficiency anaemia.	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).	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.
Primary	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	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)).