Efficacy and Safety of Bovine Intestinal Alkaline Phosphatase (bIAP) During Heart Surgery - Full Text View

Sponsor:	Alloksys Life Sciences B.V.
Collaborator:	Aix Scientifics
Information provided by:	Alloksys Life Sciences B.V.
ClinicalTrials.gov Identifier:	NCT01144611

Purpose

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.

Condition	Intervention	Phase
Inflammation	Drug: bIAP bolus and 8h infusion Drug: placebo bolus and 8h infusion	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Bypass Surgery Heart Surgery

U.S. FDA Resources

Further study details as provided by Alloksys Life Sciences B.V.:

Primary Outcome Measures:

TNF-alpha [ Time Frame: one day before till 5 days post surgery ] [ Designated as safety issue: No ]
as indicator of post-surgical inflammatory response

Secondary Outcome Measures:

incidence of new organ dysfunctions [ Time Frame: till 30 days post surgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	228
Study Start Date:	April 2010
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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.	Drug: bIAP bolus and 8h infusion intravenous as a bolus of bIAP (bovine intestinal alkaline phosphatase, 1000 IU) just prior to surgery followed by a 40 IU/kg bIAP infusion during the first 8 hours post surgery.
Placebo Comparator: placebo intravenous as a bolus just prior to surgery followed by an infusion during the first 8 hours post surgery.	Drug: placebo bolus and 8h infusion intravenous as a bolus just prior to surgery followed by an infusion during the first 8 hours post surgery.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144611

Locations

Netherlands
Catharina Ziekenhuis, Dept. CardioThoracic Surgery	Recruiting
Eindhoven, Netherlands, 5623 EJ
Contact: Esther van Dooren +31-40-2398688 esther.v.dooren@catharina-ziekenhuis.nl
Principal Investigator: M.Erwin S.H. Tan, Prof.Dr.med.

Sponsors and Collaborators

Alloksys Life Sciences B.V.

Aix Scientifics

Investigators

Principal Investigator:

M.Erwin S.H. Tan, Prof.Dr.med.

Catharina Ziekenhuis, Dept. CardioThoracic Surgery

More Information

No publications provided

Responsible Party:	Dr. Ruud Brands, Alloksys Life Sciences B.V.
ClinicalTrials.gov Identifier:	NCT01144611 History of Changes
Other Study ID Numbers:	ALS-002-2009, 2009-010191-19
Study First Received:	June 14, 2010
Last Updated:	June 14, 2010
Health Authority:	European Union: European Medicines Agency

Keywords provided by Alloksys Life Sciences B.V.:

valve replacement
CABG
SIRTS
Combined aortic valve replacement and CABG surgery

Additional relevant MeSH terms:

Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012