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Efficacy and Safety Study on bIAP (APPIRED)

Primary Purpose

Coronary Artery Disease, Endotoxin-mediated Complications From Cardiopulmonary Bypass Surgery

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
bIAP
Placebo
Sponsored by
Catharina Ziekenhuis Eindhoven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or non-pregnant, non-lactating female patients of any race in the ages of >18 years. Women must be of non-childbearing potential.
  2. Patients scheduled for coronary artery bypass surgery with CPB.
  3. Patients must have a EuroSCORE (Appendix I) of >2 and <6.
  4. Patients who have given written informed consent prior to participation in the trial and who undertake to comply with the protocol.

Exclusion Criteria:

  1. Patients who are unwilling or unable to be fully evaluated for follow-up.
  2. Patients who undergo CABG for emergency due to complications from percutaneous transluminal coronary angioplasty (PTCA)/ catheterization, unstable angina or ongoing myocardial infarction.

  3. Patients who have base alkaline phosphatase levels at > 100 IU/l (70 IU/L as mean concentration) levels, or levels < 30 IUnits/L (ammediol, DEA units)

    (values base levels in glycine units at pH9.6 and 25 C are respectively >40 and < 12 IU/L).

  4. Patients who show pre-operative infections or who are suspected of having endocarditis or systemic infection.
  5. Patients who refuse to accept medically-indicated blood products.
  6. Patients who have evidence of significant hepatic disease, including history of clinical signs or laboratory values of total bilirubin > 2.0 mg/dL, ALT or AST> 3X upper limit of normal.
  7. 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.
  8. Patients who require pre-operative ventilatory support.
  9. Patients who have renal insufficiency (history of creatinine> 2.0 mg/dL) or chronic renal failure requiring dialysis.
  10. Patients who are planned to receive leukocyte-depletion filtration as part of the bypass circuitry.
  11. Patients with severe neurological deficits (see Appendix I).
  12. Patients who have a recent history of substance or alcohol abuse.
  13. Patients with a diagnosis of idiopathic thrombocytopenia.
  14. Concomitant surgical procedures (i.e., not included in Appendix VI) anticipated to require greater than 2.5 hours time "on-pump" or patients for whom surgery other than coronary artery bypass surgery is planned during the 30-day study period.
  15. 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. If the cancer has not resolved completely, the patient should not be enrolled without permission of Alloksys.
  16. 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 the operation.
  17. Patients who are vegetarians or vegenists or those patients that may be expected not to be tolerant for bovine proteins.
  18. Patients who have a BMI (body mass index) < 18 or > 30
  19. Patients who are, in the opinion of the Investigator or the Sponsor, unsuitable for the study.

Sites / Locations

  • Catharina hospital, dept. of Cardiothoracic Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

bIAP

Placebo

Arm Description

Dosage 200 IU bIAP/kg: 1000 IU prior to anaesthesia administered as a bolus followed by intravenous continuous infusion of 5,6 IU/kg/hr for approximately 36 hours.

Outcomes

Primary Outcome Measures

To determine the efficacy and safety of bIAP as a prophylaxis against endotoxin-mediated complications from cardiopulmonary bypass surgery

Secondary Outcome Measures

Full Information

First Posted
November 9, 2009
Last Updated
November 9, 2009
Sponsor
Catharina Ziekenhuis Eindhoven
Collaborators
Alloksys Life Sciences B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT01010724
Brief Title
Efficacy and Safety Study on bIAP
Acronym
APPIRED
Official Title
A Randomized, Double-Blind, Placebo Controlled Study of Biap, an Endotoxin Detoxificating Moiety, in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Catharina Ziekenhuis Eindhoven
Collaborators
Alloksys Life Sciences B.V.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study drug bIAP, or matching placebo, will be administered as a bolus of 1000 Units bIAP or matching placebo prior to anaesthesia (T = -15 minutes), directly followed by intravenous continuous infusion of about 5.6 units per kg bodyweight/hr at pump rate 4 ml/hr for approximately 36 hrs (total 200 IU/kg/36 hrs) into each of a total of 50 patients scheduled for coronary artery bypass graft surgery (CABG). Risk of surgical complications and mortality due to co-morbid conditions will be collected and the EuroSCORE will be used to screen patients prior to surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Endotoxin-mediated Complications From Cardiopulmonary Bypass Surgery

7. Study Design

Study Phase
Phase 3

8. Arms, Groups, and Interventions

Arm Title
bIAP
Arm Type
Experimental
Arm Description
Dosage 200 IU bIAP/kg: 1000 IU prior to anaesthesia administered as a bolus followed by intravenous continuous infusion of 5,6 IU/kg/hr for approximately 36 hours.
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
bIAP
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
To determine the efficacy and safety of bIAP as a prophylaxis against endotoxin-mediated complications from cardiopulmonary bypass surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or non-pregnant, non-lactating female patients of any race in the ages of >18 years. Women must be of non-childbearing potential. Patients scheduled for coronary artery bypass surgery with CPB. Patients must have a EuroSCORE (Appendix I) of >2 and <6. 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 undergo CABG for emergency due to complications from percutaneous transluminal coronary angioplasty (PTCA)/ catheterization, unstable angina or ongoing myocardial infarction. Patients who have base alkaline phosphatase levels at > 100 IU/l (70 IU/L as mean concentration) levels, or levels < 30 IUnits/L (ammediol, DEA units) (values base levels in glycine units at pH9.6 and 25 C are respectively >40 and < 12 IU/L). Patients who show pre-operative infections or who are suspected of having 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 > 2.0 mg/dL, ALT or AST> 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> 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 (see Appendix I). Patients who have a recent history of substance or alcohol abuse. Patients with a diagnosis of idiopathic thrombocytopenia. Concomitant surgical procedures (i.e., not included in Appendix VI) anticipated to require greater than 2.5 hours time "on-pump" or patients for whom surgery other than coronary artery bypass surgery is planned during the 30-day study period. 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. If the cancer has not resolved completely, the patient should not be enrolled without permission of Alloksys. 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 the operation. Patients who are vegetarians or vegenists or those patients that may be expected not to be tolerant for bovine proteins. Patients who have a BMI (body mass index) < 18 or > 30 Patients who are, in the opinion of the Investigator or the Sponsor, unsuitable for the study.
Facility Information:
Facility Name
Catharina hospital, dept. of Cardiothoracic Surgery
City
Eindhoven
ZIP/Postal Code
5623EJ
Country
Netherlands

12. IPD Sharing Statement

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Efficacy and Safety Study on bIAP

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