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 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT03295851
Eligibility Criteria:
Inclusion Criteria:
* Elective major benign or malignant abdominal surgery
* Procedures expected to last 2 hours and/or more OR Anticipated blood loss greater than 500ml
* PAC clinic scheduled before 1 - 4 weeks before surgery
* Male Hb less than 13.0 Gram Per Deciliter OR Female Hb less than 12.0 Gram Per Deciliter
* Diagnosed as having Iron Deficiency: Serum Ferritin level less than 100 Microgram Per Liter OR Serum Ferritin is between less than100 Microgram Per Liter - less than 300 Microgram Per Liter + Transferrin Saturation is less than 20 percent
* Patient is able to receive the infusion 1 - 4 Weeks \[at least 7 Days\] before the planned operation date.
* Patient is able to provide written, informed consent
Exclusion Criteria:
* Know history of acquired iron overload
* Family history of hemochromatosis or thalassemia or transferrin saturation (TSAT) more than 50 percent
* Treatment with erythropoietin in the previous 12 weeks (3months)
* Known hypersensitivity to Ferric Carboxymaltose or its excipients
* Patients with severe asthma or severe allergy (requiring hospitalization within the last 12 months)
* Pregnancy
* Age less than 21 years
* Inability to communicate or understand study instructions and questionnaire which will be provided in either English, Chinese, Malay or Tamil
* Patient involvement in another Investigational Medicinal Product Trial within the previous 4 weeks prior to randomization that may impact the results of the PIRCAS trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03295851
Study Brief:
Protocol Section:
NCT03295851