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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01144611
Recruitment Status : Completed
First Posted : June 15, 2010
Last Update Posted : September 20, 2016
Sponsor:
Collaborator:
Aix Scientifics
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Inflammation Drug: bIAP bolus and 8h infusion Drug: placebo bolus and 8h infusion Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. TNF-alpha [ Time Frame: one day before till 5 days post surgery ]
    as indicator of post-surgical inflammatory response


Secondary Outcome Measures :
  1. incidence of new organ dysfunctions [ Time Frame: till 30 days post surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144611


Locations
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Netherlands
Catharina Ziekenhuis, Dept. CardioThoracic Surgery
Eindhoven, Netherlands, 5623 EJ
Sponsors and Collaborators
Alloksys Life Sciences B.V.
Aix Scientifics
Investigators
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Principal Investigator: M.Erwin S.H. Tan, Prof.Dr.med. Catharina Ziekenhuis, Dept. CardioThoracic Surgery
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Responsible Party: Alloksys Life Sciences B.V.
ClinicalTrials.gov Identifier: NCT01144611    
Other Study ID Numbers: ALS-002-2009
2009-010191-19 ( EudraCT Number )
First Posted: June 15, 2010    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: June 2011
Keywords provided by Alloksys Life Sciences B.V.:
valve replacement
CABG
SIRTS
Combined aortic valve replacement and CABG surgery
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes