Efficacy and Safety of Bovine Intestinal Alkaline Phosphatase (bIAP) During Heart Surgery (NCT01144611) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Bovine Intestinal Alkaline Phosphatase (bIAP) During Heart Surgery
Netherlands53 participantsStarted 2010-04
Plain-language summary
This multi-centre prospective, randomised, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of bovine intestinal alkaline phosphatase (bIAP) in reducing the pro-inflammatory post-surgical responses and thereby preserving organ functions in patients undergoing invasive cardiac surgery: combined aortic valve replacement and coronary artery bypass grafting.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or non-pregnant, non-lactating female patients of any race in the ages of \>18 years.
* Patients scheduled for combined aortic valve replacement and CABG surgery.
* Patients who have given written informed consent prior to participation in the trial and who undertake to comply with the protocol.
Exclusion Criteria:
* Patients who are unwilling or unable to be fully evaluated for follow-up.
* Patients who have base AP levels at \> 125 IU/L, or levels \< 30 IU/L (ammediol, DEA (diethanolamine) units)
* Patients who show pre-operative infections or who are suspected of endocarditis or systemic infection.
* Patients who refuse to accept medically-indicated blood products.
* Patients who have evidence of significant hepatic disease, including history of clinical signs or laboratory values of total bilirubin \> 34.2 µmol/L (\> 2.0 mg/dL), ALT (\>120) or AST (\>135) corresponding to \> 3X upper limit of normal.
* Patients who received investigational drugs in the 30 days prior to study drug administration, or are currently participating in a study during which the administration of investigational drugs within one month is anticipated.
* Patients who require pre-operative ventilatory support.
* Patients who have renal insufficiency (history of creatinine \>177mol/L or \>2.0 mg/dL) or chronic renal failure requiring dialysis.
* Patients who are planned to receive leukocyte-depletion filtration as part of the bypass circuitry.
* Patients with severe neuro…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
TNF-alpha
Timeframe: one day before till 5 days post surgery