Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-24 @ 12:17 PM
NCT ID:
NCT01912261
Eligibility Criteria:
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 than 50% at discharge
* History of Fibromyalgia
* Current diagnosis of depressive disorder
* History of Hypothyroidism includes uncontrolled thyroid disease (abnormal Thyroid Stimulating Hormone (TSH) or Thyroxine (T4) at screening visit) as per the Investigator's clinical judgment
* Patient taking iron supplementation ≤ 60 days before surgery and in the postoperative period
* Any other unstable conditions as per the Investigator's clinical judgment
* Contraindications to the six-minute walk test
* Physical disability preventing safe performance
* Resting heart rate \> 120 beats/min 10 min after rest (relative contraindications)
* Systolic blood pressure \>180mm ± Diastolic blood pressure \> 100mm Hg (relative contraindications)
* Resting Sp02 \<85% on room air or on a prescribed level of supplemental oxygen
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT01912261
Study Brief:
Protocol Section:
NCT01912261