A Randomized, Double-blind, Placebo-controlled Phase IIIa Study on bIAP, an Anti-inflammatory Moiety, in Patients Undergoing Combined Aortic Valve Replacement and Coronary Artery Bypass Grafting
Overview
- Phase
- Phase 3
- Intervention
- bIAP bolus and 8h infusion
- Conditions
- Inflammation
- Sponsor
- Alloksys Life Sciences B.V.
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- TNF-alpha
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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 neurological deficits.
Arms & Interventions
bIAP
intravenous as a bolus of bIAP (alkaline phosphatase, 1000 IU) just prior to surgery followed by a 40 IU/kg bIAP infusion during the first 8 hours post surgery.
Intervention: bIAP bolus and 8h infusion
placebo
intravenous as a bolus just prior to surgery followed by an infusion during the first 8 hours post surgery.
Intervention: placebo bolus and 8h infusion
Outcomes
Primary Outcomes
TNF-alpha
Time Frame: one day before till 5 days post surgery
as indicator of post-surgical inflammatory response
Secondary Outcomes
- incidence of new organ dysfunctions(till 30 days post surgery)