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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Alloksys Life Sciences B.V..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Aix Scientifics
Information provided by:
Alloksys Life Sciences B.V.
ClinicalTrials.gov Identifier:
NCT01144611
First received: June 14, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  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 3

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:

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 June 18, 2013