Clinical trial NCT01144611: Efficacy and Safety of Bovine Intestinal Alkaline Phosphatase (bIAP) During Heart Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammation
Keywords: valve replacement
CABG
SIRTS
Combined aortic valve replacement and CABG surgery
Lead sponsor: Alloksys Life Sciences B.V.
Sponsor class: INDUSTRY
Collaborators: name: Aix Scientifics
First posted: 2010-06-15
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.
* 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.

Primary outcomes:
measure: TNF-alpha
timeFrame: one day before till 5 days post surgery
Secondary outcomes:
measure: incidence of new organ dysfunctions
timeFrame: till 30 days post surgery
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis, Dept. CardioThoracic Surgery
Study officials:
affiliation: Catharina Ziekenhuis, Dept. CardioThoracic Surgery
name: M.Erwin S.H. Tan, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: