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:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT01225094
Eligibility Criteria:
Inclusion Criteria:
* Elective repair of an AAA (excludes thoracic or thoracoabdominal aneurysms)
* 18 years of age or older
* Able to provide informed consent
* Has one or more of the following criteria at time of preoperative assessment:
* x Open repair OR
* x Endovascular repair with ≥ 1 of the following criteria:
* o diabetes mellitus treated with insulin or oral hypoglycemic agents
* o age \> 70 years
* o pre-existing renal impairment (baseline serum creatinine level \>177 μmol/L for men or \>146 μmol/L for women)
* If diabetic, is able and willing to collect and record glucose levels at home
Exclusion Criteria:
* emergent or urgent repair (repair \< 3 days from pre-admission visit; ruptured AAA)
* prior renal transplantation
* pregnant or breastfeeding
* active gastrointestinal reflux disease, gastrointestinal ulcers or hepatobiliary disease (including gallstones)
* has active liver disease
* evidence of AKI (\> 50% increase in serum creatinine) in the 30 days prior to repair
* enrolled in another randomized controlled trial
* receipt of ≥ 1 dialysis treatment in the past week
* previous participation in this trial
* repair is scheduled \> 90 days from date of informed consent
* unable to provide written consent
* allergy(ies) to any member of the Zingiberaceae family: turmeric, ginger, curry, cumin, cardamom)
* allergy(ies) to ingredients of the study product or placebo: yellow or red food coloring, gelatin or cellulose
* have a history of major bleeding event in the previous 6 months
* bleeding disorders: a diagnosis of hemophilia, von Willebrand disease, platelets less than 70 for any reason
* history of hypoglycemia in the past 6 months: blood sugar less than or equal to 3.5 mmol/L
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01225094
Study Brief:
Protocol Section:
NCT01225094