Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05292001
Study type	Interventional
Source	Oregon Health and Science University
Contact	Karalynn J Lancaster, B.S.
Phone	5034945348
Email	lancaska@ohsu.edu
Status	Recruiting
Phase	Phase 4
Start date	June 1, 2022
Completion date	May 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT04470895` - Impact of Drugs on the Risk of Falls in the Fracture Department of the Paris Saint-Joseph Hospital Group
Recruiting	`NCT02635022` - Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
Unknown status	`NCT02013986` - Effects of Etomidate on Postoperative Circadian Rhythm Changes of Salivary Cortisol in Children	Phase 4
Terminated	`NCT01248182` - Bone to Skin Thickness Study: Obese Versus Normal Population	N/A
Recruiting	`NCT00969839` - NovaLign Intramedullary Fixation System (IFS) for the Treatment of Humeral Fractures	Phase 4
Completed	`NCT00115180` - Racial and Ethnic Disparities in Acute Pain Control	N/A
Completed	`NCT00520442` - Acute Pediatric Fracture Analgesia Study	N/A
Recruiting	`NCT04947722` - The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care	N/A
Recruiting	`NCT06107699` - The CHARM Study-Coordinating Transitions From Hospital for Older Adults With Fractures	N/A
Completed	`NCT04532580` - Clinical Validation of Boneview for FDA Submission
Completed	`NCT04237454` - Thermal Imaging Compared to Skeletal Survey in Children Below 2 Years	N/A
Recruiting	`NCT05002335` - Clinical and Radiological Outcomes of Medacta Shoulder System (BE)
Completed	`NCT02591043` - Surgical Treatment of Low Energy Pelvic Fractures in the Elderly	N/A
Completed	`NCT02933359` - Osteogenic Profiling of Normal Calvarial Bone
Completed	`NCT01049191` - Bone Microarchitecture in Women With and Without Fracture	N/A
Completed	`NCT03431857` - Multi Centre Study on TESS V2 Shoulder System
Recruiting	`NCT04133103` - Early Mobilisation in the Surgical Robot Assisted Spinal Surgery	N/A
Completed	`NCT03993691` - Wrist Fracture Evaluation With a Desktop Orthopedic Tomosynthesis System	N/A
Active, not recruiting	`NCT01719887` - Effectiveness and Cost-effectiveness of Surgical Treatment of Humeral Shaft Fractures. Randomized Controlled Trial	N/A
Completed	`NCT02786498` - Optimal Vitamin D3 Supplementation Strategies for Acute Fracture Healing	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.