Clinical trial NCT02047552 (phase 2, status: withdrawn)
Conditions: functional iron deficiency, trauma, anemia
ICD codes: K08.81, K08.82, O71.9, N48.31, O71.89, G89.11, G89.21, D53.2, D64.9, D46.4, D53.0, D53.9, D61.3, D61.9
Drugs: iron sucrose, oxandrolone, iv iron placebo, oxandrolone placebo
SMILES: O.O.O.[OH-].[O--].[O--].[O--].[O--].[O--].[O--].[O--].[O--].[Na+].[Na+].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O, [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@]12C, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@]12C
Reason stopped: 
    no participants enrolled
  
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.