Clinical trial: RCT of Goal-directed Iron Supplementation of Anemic, Critically Ill Trauma Patients, With and Without Oxandrolone (NCT02047552)

Eligibility 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug.  Blood pressure is 120/80 mm Hg and pulse is 70/min.  Oxygen saturation is 99% on room air.  BMI is 24 kg/m2.  Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis.

Patient description (patient's own words): I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550  μg/L. The doctor diagnosed me with iron overload.

Does the patient match the trial criteria? Contradiction