RCT of Goal-directed Iron Supplementation of Anemic, Critically Ill Trauma Patients, With and Without Oxandrolone

• Status: Withdrawn
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to determine if the combination of goal directed iron supplementation and hepcidin mitigation can safely eliminate both the serum and bone marrow iron debt of anemic, critically ill trauma patients with functional iron deficiency.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Denver Health and Hospital Authority
• Treatments: Ferric Compounds; Ferric Oxide, Saccharated; Iron; Oxandrolone

Criteria

Inclusion Criteria:

1. Informed consent from patient or patient representative.

2. Trauma patient

3. Anemia (hemoglobin < 12 g/dL).

4. Functional iron deficiency:

1. Serum iron concentration < 40 ug/dL

2. TSAT < 25%

3. Serum ferritin concentration > 28 ng/mL

5. < 72 hours from ICU admission.

6. Expected ICU length of stay ≥ 7 days.

Exclusion Criteria:

1. Age < 18 years.

2. Active bleeding requiring pRBCs transfusion.

3. Iron overload (serum ferritin concentration ≥ 1,500 ng/mL). The serum ferritin concentration is an acute phase reactant that is increased during critical illness regardless of total body iron. Substantial levels of hyperferritinemia (serum ferritin concentration > 1,000 ng/dL) were observed in both NCT00450177 and NCT01180894 without increased risk of infection and despite both low TSAT and IDE. For these reasons, we believe that relative hyperferritinemia (serum ferritin concentration 500 - 1,500 ng/dL) is neither harmful nor indicative of bone marrow iron availability.

4. Infection, defined using US Centers for Disease Control and Prevention (CDC) guidelines, with the exception of ventilator-associated pneumonia (VAP), which is defined as clinical suspicion for pneumonia along with a lower respiratory tract culture with ≥ 105 colony forming units per mL.

5. Chronic inflammatory conditions (e.g., systemic lupus erythematosis, rheumatoid arthritis, ankylosing spondylitis).

6. Pre-existing hematologic disorders (e.g., thalassemia, sickle cell disease, hemophilia, von Willibrand's disease, or myeloproliferative disease).

7. Pre-existing hepatic dysfunction (cirrhosis, non-alcoholic steatohepatitis, hepatitis)

8. Current or recent (within 30 days) use of immunosuppressive agents.

9. Use of any recombinant human erythropoietin formulation within the previous 30 days.

10. Known or suspected carcinoma of the breast or prostate.

11. Nephrosis, the nephrotic phase of nephritis.

12. Hypercalcemia (serum calcium concentration > 10.5 mg/dL).

13. Pregnancy or lactation.

14. Legal arrest or incarceration.

15. Prohibition of pRBCs transfusion.

16. Stay of ≥ 48 hours duration in the ICU of a transferring hospital.

17. History of intolerance or hypersensitivity to either iron or oxandrolone.

18. Moribund state in which death was imminent.