Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma

Phase 4

Recruiting

• Conditions: Fracture; Acute Blood Loss Anemia
• Interventions: Drug: Iron-Dextran Complex Injection [InFed]; Other: Saline Placebo

• Registration Number: NCT05292001
• Lead Sponsor: Oregon Health and Science University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-10
• Study First Submitted QC: 2022-03-18
• Study First Posted: 2022-03-23
• Study Start: 2022-06-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-29
• Last Update Posted: 2023-02-10
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Iron-Dextran Complex Injection [InFed]	Single infusion of low molecular weight Iron Dextran
Placebo	Saline Placebo	Single infusion of normal saline

Primary Outcome Measures

Name	Time	Method
Rate of participant enrollment and screen failures	3 months	Appraisal of feasibility based on rate of participant enrollment per year and rate of screening failures.
Patient Reported Outcome Scores: Fatigue	3 months	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.
Evaluation of protocol adherence	3 months	Appraisal of feasibility based on proportion of participants completing each follow up visit and proportion of missing data.

Secondary Outcome Measures

Name	Time	Method
Rate of anemia and anemia resolution in participants	3 months	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.
Patient Reported Outcome Scores - Depression	3 months	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.
Evaluation of ferritin level in response to IVIT after trauma	3 months	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	3 months	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 - Physical Function	3 months	PROMIS bank v1.2 - physical function. Computer adaptive survey which measures self-reported capability to perform physical activities including activities of daily living. Scored on the T-score metric (average score 50, standard deviation 10). High scores mean more of the concept being measured.
Patient Reported Outcome Scores - Quality of Life	3 months	EQ-5D-5L Quality of Life Questionnaire. Instrument assesses five dimensions of health, corresponding to 3,125 possible health states that can be converted into a single 'utility' score. This will be utilized for the assessment of quality-adjusted life years (QALYs) and cost effectiveness of IVIT for the treatment of acute blood loss anemia following surgical fracture stabilization. Scored from 0-100, 100 being the best health state and 0 being the worst.

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States