Efficacy and Safety of Bovine Intestinal Alkaline Phosphatase (bIAP) During Heart Surgery

NCT ID: NCT01144611

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2013-12-31

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.

Conditions

Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

bIAP bolus and 8h infusion

Intervention Type: DRUG

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

intravenous as a bolus just prior to surgery followed by an infusion during the first 8 hours post surgery.

Group Type: PLACEBO_COMPARATOR

placebo bolus and 8h infusion

Intervention Type: DRUG

intravenous as a bolus just prior to surgery followed by an infusion during the first 8 hours post surgery.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aix Scientifics

INDUSTRY

Sponsor Role: collaborator

Alloksys Life Sciences B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Catharina Ziekenhuis, Dept. CardioThoracic Surgery

Locations

Catharina Ziekenhuis, Dept. CardioThoracic Surgery

Eindhoven, , Netherlands

Countries

Netherlands

Other Identifiers

2009-010191-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ALS-002-2009

Identifier Type: -

Identifier Source: org_study_id