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NCT05292001 · ClinicalTrials.gov registry record · Phase 4
Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma
A Phase 4 study of Fracture and Acute Blood Loss Anemia, sponsored by Oregon Health and Science University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT05292001: Recruiting Phase 4 study of Fracture and Acute Blood Loss Anemia, sponsored by Oregon Health and Science University.
NCT05292001 is a Phase 4 study of Fracture and Acute Blood Loss Anemia that is actively recruiting participants, run by Oregon Health and Science University. The registered enrollment target is 150 participants, below the 4,685-participant average among 9 other Fracture trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05292001, a Phase 4 study of Fracture and Acute Blood Loss Anemia, is actively recruiting participants, sponsored by Oregon Health and Science University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Appraisal of feasibility based on rate of participant enrollment per year and rate of screening failures.
Conditions Studied
Interventions
- OTHER Saline Placebo
- DRUG Iron-Dextran Complex Injection [InFed]
Study Locations (1)
Oregon
- Oregon Health & Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2022-06-01 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 4 |
What NCT05292001 shows while recruiting
NCT05292001 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 4,685-participant average among 9 other Fracture trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Fracture appearing as the primary indexed condition, and to 2 interventions - of which Saline Placebo is the first listed.
NCT05292001 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT05292001 about?
NCT05292001 is a clinical study titled "Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma". 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 implication...
What is the current status of trial NCT05292001?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2022-06-01. Estimated completion is 2026-05-31.
What conditions does trial NCT05292001 study?
This clinical trial studies the following conditions: Fracture, Acute Blood Loss Anemia.
What interventions are being tested in trial NCT05292001?
The interventions under investigation include: Saline Placebo (OTHER), Iron-Dextran Complex Injection [InFed] (DRUG).
Who is sponsoring clinical trial NCT05292001?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05292001 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05292001's enrollment target sits among peer trials
150 4th of 9 higher than 6 of 9 other Fracture trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fracture trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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