NCT01144611CompletedPhase 3
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Alloksys Life Sciences B.V.
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- TNF-alpha
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Patients who have a recent history of drug or alcohol abuse.
- •Patients with a diagnosis of idiopathic thrombocytopenia.
- •Patients with a history of cancer who have received chemotherapy or radiation therapy within the past 3 months. Patients receiving only adjuvant hormonal therapy are not excluded.
- •Patients who are scheduled to receive "stress doses" of glucocorticoids (i.e., doses >2 mg/kg/day of methylprednisolone or equivalent) prior to, during or following surgery.
- •Patients who are vegetarians or veganists or those patients that may be expected not to be tolerant for bovine proteins.
- •Patients who are, in the opinion of the investigator, unsuitable for the study. A well-documented screening log should be present in the clinic.
Arms & Interventions
bIAP
Active Comparator
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 (Drug)
placebo
Placebo Comparator
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 (Drug)
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)
Investigators
Study Sites (1)
Loading locations...
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