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

NCT02047552 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-04-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Iron sucrose

Iron sucrose 100 mg IV will be dosed daily for up to seven days if, on morning laboratory analysis, (1) TSAT \< 25%, (2) Serum iron concentration \< 150 ug/mL, and (3) Serum ferritin concentration \< 1,500 ng/mL. Thus, the maximum possible cumulative dose of iron sucrose over the one-week dosing period will be 700 mg.

DRUG

Oxandrolone

10 mg PO Q12 hours for seven days

DRUG

IV iron placebo

100 mL normal saline

DRUG

Oxandrolone placebo

similar color and size sugar pill

Sponsors & Collaborators

  • Denver Health and Hospital Authority

    lead OTHER

Principal Investigators

  • Fredric M Pieracci, MD, MPH · Denver Health Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02047552 on ClinicalTrials.gov