Status:
COMPLETED
Efficacy and Safety of Bovine Intestinal Alkaline Phosphatase (bIAP) During Heart Surgery
Lead Sponsor:
Alloksys Life Sciences B.V.
Collaborating Sponsors:
Aix Scientifics
Conditions:
Inflammation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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-i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01144611
Start Date
April 1 2010
End Date
December 1 2013
Last Update
September 20 2016
Active Locations (1)
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1
Catharina Ziekenhuis, Dept. CardioThoracic Surgery
Eindhoven, Netherlands, 5623 EJ