Preoperative Intravenous Iron Infusion to Reduce Post-surgical Complications: a Pilot Randomised Control Trial

• Status: Unknown status
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Preoperative anemia is common worldwide, ranging from 25% in knee arthroplasties to 60% in colorectal malignancies. In Singapore, about a quarter (27%) of all patients have anaemia prior to operation at a main tertiary center. Currently, the rate of preoperative anemia in Singapore General Hospital (SGH) is 26.6%.

This is an alarming public health issue as the negative impact of preoperative anemia on post-surgical outcomes has been well documented and include increased rates of perioperative blood transfusion, mortality, adverse cardiac and non-cardiac complications including pulmonary complications, wound infections, systemic sepsis and venous thromboembolism, as well as prolonged length of hospital stay and increased healthcare costs. These data suggest that reducing preoperative anemia prior to major surgery is imperative to improve clinical outcomes and decrease healthcare costs.

This study responds to an urgent need to optimize the current standard practice for managing preoperative anemia. It is designed as a randomised, open-label, study to investigate the efficacy of intravenous iron compared to oral iron in patients with anemia undergoing major surgery to reduce surgical complications. To demonstrate the feasibility of conducting such trial in a larger scale, a pilot study with the same design will be conducted. The findings of this pilot study will also inform the study design and sample size for the larger study.

If successful, the results will inform clinical practice guidelines, result in better patient and clinical outcomes, reduce burden on the health care system, and change health-related policy. For example, all forms of intravenous iron therapy are currently not subsidized by the Singapore government which is in stark contrast with allogenic blood transfusion, which is subsidised and readily available at a substantially reduced rate to patients. Hence, it will cost the patients more out of pocket to be treated with intravenous iron than to have allogenic blood transfusion. Incorporating a preoperative anemia correction protocol in the current surgical pathway is a potential strategy to combat healthcare cost inflation and the increasing demand for blood products.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Singapore General Hospital
• Collaborators: Duke-NUS Graduate Medical School; Duke-NUS Medical School
• Treatments: Ferric Compounds; Ferrous fumarate; Iron

Criteria

Inclusion Criteria:

• Elective major benign or malignant abdominal surgery

• Procedures expected to last 2 hours and/or more OR Anticipated blood loss greater than 500ml

• PAC clinic scheduled before 1 - 4 weeks before surgery

• Male Hb less than 13.0 Gram Per Deciliter OR Female Hb less than 12.0 Gram Per Deciliter

• Diagnosed as having Iron Deficiency: Serum Ferritin level less than 100 Microgram Per Liter OR Serum Ferritin is between less than100 Microgram Per Liter - less than 300 Microgram Per Liter + Transferrin Saturation is less than 20 percent

• Patient is able to receive the infusion 1 - 4 Weeks [at least 7 Days] before the planned operation date.

• Patient is able to provide written, informed consent

Exclusion Criteria:

• Know history of acquired iron overload

• Family history of hemochromatosis or thalassemia or transferrin saturation (TSAT) more than 50 percent

• Treatment with erythropoietin in the previous 12 weeks (3months)

• Known hypersensitivity to Ferric Carboxymaltose or its excipients

• Patients with severe asthma or severe allergy (requiring hospitalization within the last 12 months)

• Pregnancy

• Age less than 21 years

• Inability to communicate or understand study instructions and questionnaire which will be provided in either English, Chinese, Malay or Tamil

• Patient involvement in another Investigational Medicinal Product Trial within the previous 4 weeks prior to randomization that may impact the results of the PIRCAS trial