Clinical trial for Acute Blood Loss Anemia
Official title Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma
ClinicalTrials.gov ID: NCT05292001
What this study is testing
What is Iron-Dextran Complex Injection [InFed]?
This is an investigational intravenous iron medicine being studied to help treat anemia caused by acute blood loss in orthopaedic trauma patients. It is designed to provide the body with iron, which is needed to make new red blood cells.
Also referred to as INFeD.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if giving iron through a vein helps people recover their normal blood levels faster after a serious injury. It also looks at how this treatment affects energy, physical ability, and mood.
- Who it's for
- People who have had a bone fracture or other orthopedic injury and have low blood counts (anemia).
- What's involved
- Participants will receive iron through an IV line. They will have regular blood tests and fill out questionnaires about their energy levels, physical function, and mood.
- Time commitment
- The study involves multiple visits over time to track recovery and complete required tests.
- Phase 4: studies an already-approved treatment
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89
You may be able to join if
- 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...
You likely can't join if
- 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...
- Pre-existing hematologic or coagulation disorder (e.g., thalassemia, sickle cell disease, hemophilia, von Willibrand's disease, or myeloproliferative...
- Diagnosis of chronic kidney disease and/or chronic liver disease
- Known infection, inflammatory condition (e.g., systemic lupus erythematosus, rheumatoid arthritis, and ankylosing spondylitis), or malignancy
See the full eligibility criteria
- 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
- 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...
- Pre-existing hematologic or coagulation disorder (e.g., thalassemia, sickle cell disease, hemophilia, von Willibrand's disease, or myeloproliferative disease)
- Diagnosis of chronic kidney disease and/or chronic liver disease
- Known infection, inflammatory condition (e.g., systemic lupus erythematosus, rheumatoid arthritis, and ankylosing spondylitis), or malignancy
- Pregnancy
- Iron overload (defined as serum ferritin concentration ≥ 1,000ng/mL, serum iron concentration \> 160μg/ dL, or serum transferrin saturation ≥ 50%) or any condition associated with iron overload (e.g., hemochromatosis...
- Patients that are tenets of the Jehovah's Witness faith
- Vulnerable populations including pediatric patients, geriatric populations 90 or older, incarcerated individuals, those unable to provide informed consent
- Inability to refrain from oral iron supplementation during study period
- Current or recent (within 30 days) use of immunosuppressive agents
- Use of any intravenous iron therapy or recombinant human erythropoietin formulation within the previous 30 days
The study team makes the final eligibility decision.
Where it is enrolling
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Portland, Oregon, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.