Effects of Oral Iron on Postoperative Fatigue Upon Coronary Artery Bypass Graft Patients (NCT01912261) | Clinical Trial Compass
TerminatedPhase 3
Effects of Oral Iron on Postoperative Fatigue Upon Coronary Artery Bypass Graft Patients
Stopped: The study was stopped due to time constraints and resources
Canada121 participantsStarted 2014-12-16
Plain-language summary
The purpose of this research study is to examine how an oral iron supplement (Feramax®) influences fatigue during early postoperative recovery (at three months) among CABG patients and, the effects on recovery outcomes (e.g. quality of life, functional capacity, anemia, and medication adherence).
It is hypothesized that CABG surgery patients receiving oral iron (Feramax®) 150mg orally (once a day therapy) will have a 15% reduction in POF (measured by the Identity Consequence Fatigue Scale (ICFS)), compared to patients receiving a placebo.
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
• Non-Urgent, first time, coronary artery bypass grafting.
* American Society of Anesthesia (ASA) physical status II-IV
* Aged 19 years and older
* Able to make informed consent by understanding the nature of the participation
* Able to read and write English to the degree necessary to participate in interviews and questionnaires
Exclusion Criteria:
* Had prior median sternotomy surgery
* A Hemoglobin greater than or equal 120g/L at discharge
* Previous history of noncompliance with oral medications
* Received erythropoiesis-stimulating agents (e.g. epoetin alfa and darbepoetin alfa) postoperatively to discharge
* Allergy to iron History of hematological disorders that are deemed clinically significant as per the investigator's clinical judgment
* Received Clopidogrel within two days prior to surgery, greater than 81mg of Acetylsalicylic acid 24 hours prior to surgery, or have received "new oral anticoagulants" (e.g. Apixaban, Rivaroxaban, and Dabigatran) within the recommended preoperative exclusion period
* History of iron metabolism disorders e.g. known iron overload, hemochromatosis, porphyria
* Chronic fatigue syndrome (a condition that is distinguished from other types of fatigue by fatigue lasting more than six months and has at least four other symptoms (e.g. sleep disturbances, headaches, joint pain, and concentration difficulties) that could contribute to increased fatigue (Afari \& Buchwald, 2003)).
* A serum transferrin saturation of more t…