Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma
This study is looking at whether a single dose of intravenous (IV) Iron-Dextran Complex Injection (InFed) can help patients with acute blood loss anemia (low red blood cell count due to blood loss) after having surgery for a broken bone in their leg or pelvis. Anemia can cause problems like fatigue and increase risks after surgery. You might be able to join if you are 18-89 years old, have a lower extremity or pelvis fracture requiring surgery, and have acute blood loss anemia (hemoglobin between 7.0-11.0g/dL) within seven days after your surgery. The study will compare InFed to a saline placebo (a salt water solution with no medicine). Researchers will measure how many people enroll, how well the study plan is followed, and your fatigue levels after 3 months. The current status of this study is unclear.
- Study design
- This interventional study plans to enroll 150 participants. Participants will receive either a single 1000mg dose of Iron-Dextran Complex Injection (InFed) or a saline placebo.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 3 months to assess enrollment rates, protocol adherence, and fatigue scores.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Zachary M Working, MD · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Rate of participant enrollment and screen failures3 months
Appraisal of feasibility based on rate of participant enrollment per year and rate of screening failures.
- Evaluation of protocol adherence3 months
Appraisal of feasibility based on proportion of participants completing each follow up visit and proportion of missing data.
- Patient Reported Outcome Scores: Fatigue3 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.