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

NCT01144611 | Completed Phase 3

• 2 other identifiers: ALS-002-20092009-010191-19
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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

Keywords

valve replacement; CABG; SIRTS; Combined aortic valve replacement and CABG surgery

Outcome Measures

Primary Outcomes (1)

• TNF-alpha

  as indicator of post-surgical inflammatory response

  one day before till 5 days post surgery

Secondary Outcomes (1)

• incidence of new organ dysfunctions

  till 30 days post surgery

Study Arms (2)

bIAP

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

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

Interventions

bIAP bolus and 8h infusion 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.

bIAP

placebo bolus and 8h infusion DRUG

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

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alloksys Life Sciences B.V.: lead
• Aix Scientifics: collaborator

Study Sites (1)

Catharina Ziekenhuis, Dept. CardioThoracic Surgery

Eindhoven, 5623 EJ, Netherlands

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• M.Erwin S.H. Tan, Prof.Dr.med.

  Catharina Ziekenhuis, Dept. CardioThoracic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 15, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 20, 2016

Record last verified: 2011-06

Locations

NL (1)