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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014