Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma
Status:
Not yet recruiting
Trial end date:
2024-04-01
Target enrollment:
Participant gender:
Summary
Acute blood loss in orthopaedic trauma and operative fracture care contributes substantially
to perioperative anemia, which places participants at increased risk for complications
including surgical site infection, cardiovascular complications, and even death. Anemia has
further clinical implications in quality of life measures and is associated with fatigue,
impaired physical performance, decreased exercise capacity, and mood disturbances. Thus,
evaluation and treatment of perioperative anemia is critical in risk mitigation within
orthopaedic surgery. The current standard of care for anemia is transfusion of packed red
blood cells in only cases of severe anemia due to the substantial associated risks. A safer
alternative is desirable because a critical number of participants do not meet the
restrictive transfusion threshold and may suffer negative effects from anemia during recovery
from the acute insult. The focus of this project is to pilot an investigation of the benefits
of intravenous iron therapy (IVIT) in traumatically injured patients. Specifically, Aim I
will determine feasibility of study design, recruitment, randomization, intervention
implementation, blinded procedures, and retention. In Aim II, time to return to normal
hemoglobin following traumatic orthopaedic injury will be assessed. With Aim III, the
investigators will measure IVIT effect on participant-reported fatigue, physical function,
and depression, and further determine if resolution of anemia is correlated to improvements
in these measures in traumatically injured orthopaedic patients. Aim IV will focus on
evaluating the role of IVIT on immune cells through a variety of novel laboratory
assessments. The investigators expect this study to provide a better understanding of IVIT,
which has the potential to alter providers' treatment approach of anemia in participants who
sustain traumatic orthopaedic injury, thereby leading to decreased risks and improved
recovery.