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

Phase 3

Completed

• Conditions: Inflammation
• Interventions: Drug: bIAP bolus and 8h infusion; Drug: placebo bolus and 8h infusion

• Registration Number: NCT01144611
• Lead Sponsor: Alloksys Life Sciences B.V.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-06-14
• Study First Submitted QC: 2010-06-14
• Study First Posted: 2010-06-15
• Status Verified: 2011-06
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2016-09-19
• Last Update Posted: 2016-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bIAP	bIAP bolus and 8h infusion	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.
placebo	placebo bolus and 8h infusion	intravenous as a bolus just prior to surgery followed by an infusion during the first 8 hours post surgery.

Primary Outcome Measures

Name	Time	Method
TNF-alpha	one day before till 5 days post surgery	as indicator of post-surgical inflammatory response

Secondary Outcome Measures

Name	Time	Method
incidence of new organ dysfunctions	till 30 days post surgery

Trial Locations

Locations (1)

Catharina Ziekenhuis, Dept. CardioThoracic Surgery; 🇳🇱 Eindhoven, Netherlands