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:
Participant gender:
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
Details
Lead Sponsor:
Singapore General Hospital
Collaborators:
Duke-NUS Graduate Medical School Duke-NUS Medical School