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 range18 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:
* 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…
What they're measuring
1
TNF-alpha
Timeframe: one day before till 5 days post surgery