About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients age 18-89 admitted with a lower extremity or pelvis fracture requiring surgical stabilization
Acute blood loss anemia as defined by hemoglobin concentration between 7.0-11.0g/dL within seven days post-operatively from definitive fracture stabilization during the hospital admission
Disqualifiers
History of intolerance or hypersensitivity to IV iron supplementation
Active hemorrhage requiring greater than two units (whole blood or pRBCs) transfused perioperatively
1. Multiple planned operative procedures during the trauma admission, excluding orthopaedic staged procedures for the fracture meeting inclusion criterion one (such as temporizing external fixator application and washout for open fracture) in which subjects otherwise meet qualifications for enrollment after definitive stabilization
Pre-existing hematologic or coagulation disorder (e.g., thalassemia, sickle cell disease, hemophilia, von Willibrand's disease, or myeloproliferative disease)
Trial design
Parallel
Treatments tested in this trial
Iron-Dextran Complex Injection [InFed]
Drugsingle 1000mg dose
Saline Placebo
Other interventionNormal saline
Treatment groups
Trial outcomes
Primary outcomes
Rate of participant enrollment and screen failures
Appraisal of feasibility based on rate of participant enrollment per year and rate of screening failures.
Evaluation of protocol adherence
Appraisal of feasibility based on proportion of participants completing each follow up visit and proportion of missing data.
Patient Reported Outcome Scores: Fatigue
PROMIS bank v1.0 - fatigue. Computer adaptive test that measures feelings of tiredness likely to decrease one's ability to execute daily activities and function normally in family or social roles. Scored on the T-score metric (average score 50, standard deviation 10). High scores mean more of the concept being measured.
Secondary outcomes
Rate of anemia and anemia resolution in participants
Measured by the concentration of hemoglobin (oxygen carrying protein) in whole blood. This marker of anemia (defined as hemoglobin \<12g/dL in females and \<13.5g/dL in males) measured for inclusion assessment and to monitor for time to resolution of anemia at all study follow-up visits.
Evaluation of ferritin level in response to IVIT after trauma
Evaluated at enrollment to assess for iron overload (patients with a ferritin level ≥ 1,000ng/mL will be excluded) and tracked throughout the study to measure participants' body stores of iron.
Evaluation of participant body iron stores in response to IVIT after trauma
Assessment of body iron stores and iron carrying capacity within blood. Utilized to further define patients' anemia and iron available for functional use.
Patient Reported Outcome Scores - Depression
PROMIS bank v1.0 - depression. Computer adaptive survey administered to assess negative mood, views of self, social cognition, and decreased social engagement. Scored on the T-score metric (average score 50, standard deviation 10). High scores mean more of the concept being measured.
Sponsors and contacts
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Oregon Health and Science University
Lead sponsor
Collins Medical Trust
Collaborator
Medical Research Foundation
Collaborator