IV Iron for the Anemia of Traumatic Critical Illness
IATCI
A Multicenter, Randomized, Double-blind Comparison of Intravenous Iron Supplementation to Placebo for the Treatment of Anemia of Traumatic Critical Illness
1 other identifier
interventional
150
1 country
6
Brief Summary
The purpose of this clinical trial is to determine whether intravenous iron supplementation of anemic, critically ill trauma patients improves anemia and reduces the need for a red blood cell transfusion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2011
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2010
CompletedFirst Posted
Study publicly available on registry
August 12, 2010
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedResults Posted
Study results publicly available
January 20, 2017
CompletedFebruary 5, 2018
January 1, 2018
2.3 years
August 11, 2010
September 16, 2015
January 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
RBC Transfusion
The number of participants who underwent RBC transfusion.
42 Days
Secondary Outcomes (3)
Iron-deficient Erythropoeisis (IDE)
14 Days
Infection
28 Days
The Number of Participants Who Died
28 Days
Study Arms (2)
Iron sucrose
ACTIVE COMPARATOR100 mg IV TIW
Placebo
PLACEBO COMPARATORPacebo - Normal Saline
Interventions
Eligibility Criteria
You may qualify if:
- ICU admission for trauma
- Adults (age ≥ 18 years)
- Anemia (hemoglobin \< 12 g/dL)
- ≤ 72 hours from ICU admission
- Expected ICU length of stay ≥ 7 days
You may not qualify if:
- Active hemorrhage requiring RBC transfusion
- Iron overload (serum ferritin concentration ≥ 1,000 ng/mL) or any condition associated with iron overload (e.g., hemochromatosis, aceruloplasminemia
- Chronic inflammatory conditions (e.g., systemic lupus erythematosis, rheumatoid arthritis, ankylosing spondilitis)
- Pre-existing hematologic disorders (e.g., thalassemia, sickle cell disease, hemophilia, von Willibrand's disease, myeloproliferative disease)
- Macrocytic anemia (mean corpuscular volume ≥ 100 fL)
- Current use of immunosuppressive agents including corticosteroids (e.g., dexamethasone, hydrocortisone, methylprednisolone, prednisone, exclusive of inhaled corticosteroids), calcinurin inhibitors (e.g., cyclosporine, tacrolimus), antimetabolites (e.g., azathioprine), or biologics (e.g., OKT3, thymoglobulin)
- Use of recombinant human erythropoietin formulation within the prev 30 days
- Pregnancy or lactation
- Prohibition of RBC transfusion
- Stay of ≥ 48 hours duration in the ICU of a transferring hospital
- History of intolerance or hypersensitivity to either enteral or intravenous iron
- Moribund state in which death is imminent
- Enrollment in any other clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
University of Michigan Health Systems
Ann Arbor, Michigan, 48103, United States
NewYork Presbyterian Medical Center/Weill Cornell Medical College
New York, New York, 10065, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19102, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15201, United States
Harborview Medical Center/University of Washington
Seattle, Washington, 98102, United States
Related Publications (1)
Pieracci FM, Stovall RT, Jaouen B, Rodil M, Cappa A, Burlew CC, Holena DN, Maier R, Berry S, Jurkovich J, Moore EE. A multicenter, randomized clinical trial of IV iron supplementation for anemia of traumatic critical illness*. Crit Care Med. 2014 Sep;42(9):2048-57. doi: 10.1097/CCM.0000000000000408.
PMID: 24797376DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Fredric Pieracci
- Organization
- Denver Health Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Fredric M Pieracci, MD, MPH
Denver Health Medical Center, University of Colorado Health Science Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 11, 2010
First Posted
August 12, 2010
Study Start
June 1, 2011
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
February 5, 2018
Results First Posted
January 20, 2017
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share