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Pilot Study of Hemoglobin Based Oxygen Therapeutics in Elective Coronary Revascularization

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: NCT00317512
Recruitment Status : Completed
First Posted : April 25, 2006
Last Update Posted : May 16, 2008
Sponsor:
Information provided by:
Biopure Corporation

Tracking Information
First Submitted Date  ICMJE April 21, 2006
First Posted Date  ICMJE April 25, 2006
Last Update Posted Date May 16, 2008
Study Start Date  ICMJE December 2003
Actual Primary Completion Date April 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2006)
  • Safety
  • In hospital thrombotic events
  • Anaphylactic reactions
  • Inflammatory reactions
  • Substantial changes to systemic & coronary hemodynamics
  • Circulatory overload
  • Renal dysfunction
  • Untoward drug interaction effects
  • substantial changes in laboratory parameters
  • Life threatening cardiac arrhythmias
  • Other adverse events
  • Feasibility:
  • Number of subjects requiring premature discontinuation of study drug for clinical or logistical reasons
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of Hemoglobin Based Oxygen Therapeutics in Elective Coronary Revascularization
Official Title  ICMJE A Multi-Center,Randomized,Double-Blind,Placebo-Controlled,Dose Finding Pilot Study, to Evaluate Safety/Feasibility of HBOC-201 in Elective Percutaneous Coronary Revascularization of Subjects With Acute Coronary Syndromes
Brief Summary The purpose of this study is to assess the safety and feasibility of a novel oxygen carrying solution, HBOC-201, in the setting of PCI for Acute Coronary Syndromes from randomization til hospital discharge.
Detailed Description

Acute coronary syndromes are due to an acute or subacute primary reduction of myocardial oxygen supply provoked by disruption of an atherosclerotic plaque associated with inflammation, thrombosis, vasoconstriction and microembolization. Occlusive thrombosis superimposed on a ruptured atheroma in an epicardial coronary artery is firmly established as the immediate cause of an acute ST-segment Elevation Myocardial Infarction (STEMI). Rapid restoration of blood flow (oxygen supply) to jeopardized myocardium limits necrosis and reduces mortality. This can be accomplished medically with a thrombolytic agent, or mechanically, with so-called primary balloon angioplasty or stenting. Primary percutaneous coronary intervention (PCI) has become the preferred therapy for STEMI in most developed countries.

HBOC-201 is a solution belonging to a new class of biologic oxygen therapeutics, hemoglobin based oxygen carriers. HBOC-201 is a crosslinked and glutaraldehyde-polymerized hemoglobin (Hb) extracted from isolated bovine red blood cells. On a gram-for-gram basis, HBOC-201 was calculated to be approximately three times more potent than stored fresh red blood cell hemoglobin at restoring baseline tissue oxygenation following severe acute anemia. Evaluation of this Hemoglobin Based Oxygen Carrier has been undertaken in 57 preclinical studies and 21 human clinical trials. The compound is under review by the US FDA and has been approved in the Republic of South Africa. However, HBOC-201 has not yet been evaluated in the setting of this disease (narrowing of a coronary artery).

Biopure will be studying the safety and feasibility of HBOC-201 in patients with typical symptoms of Unstable Angina or Non ST-segment Elevation Myocardial Infarction eligible to undergo invasive revascularization through a PCI procedure.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Angina Pectoris
  • Unstable Angina
  • Myocardial Infarction
Intervention  ICMJE
  • Procedure: Percutaneous Coronary Revascularization
  • Drug: Hemoglobin-Based Oxygen Carrier-201 (HBOC-201)
  • Drug: Voluven
Study Arms  ICMJE
  • Active Comparator: 1
    Voluven will be administered at 7.7 ml/min over 15 minutes,followed by Voluven at 7.7 ml/min over 15 minutes
    Interventions:
    • Procedure: Percutaneous Coronary Revascularization
    • Drug: Voluven
  • Active Comparator: 2
    HBOC-201 will be administered at 7.7 ml/min over 15 minutes,followed by Voluven at 7.7 ml/min over 15 minutes
    Interventions:
    • Procedure: Percutaneous Coronary Revascularization
    • Drug: Hemoglobin-Based Oxygen Carrier-201 (HBOC-201)
    • Drug: Voluven
  • Experimental: 3
    HBOC-201 will be administered at 7.7 ml/min over 15 minutes,followed by HBOC-201 at 7.7 ml/min over 15 minutes
    Interventions:
    • Procedure: Percutaneous Coronary Revascularization
    • Drug: Hemoglobin-Based Oxygen Carrier-201 (HBOC-201)
Publications * Serruys PW, Vranckx P, Slagboom T, Regar E, Meliga E, de Winter RJ, Heyndrickx G, Schuler G, van Remortel EA, Dubé GP, Symons J. Haemodynamic effects, safety, and tolerability of haemoglobin-based oxygen carrier-201 in patients undergoing PCI for CAD. EuroIntervention. 2008 Mar;3(5):600-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2006)
45
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date April 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written informed consent provided before initiation of any study-related procedure, and before any pre-procedural sedation, and agreement to comply with all protocol-specified procedures
  • Acute Coronary Syndrome (Stable and unstable angina or non ST segment Elevation Myocardial Infarction (UA/non-STEMI) [Braunwald class I-III Class B], Appendix 1).
  • Single vessel disease of the Left Coronary Artery (LCA)
  • One vessel disease of the Right Coronary Artery (RCA)
  • Have a single de novo lesion
  • Older than 18 years and younger than 75 years of age
  • Eligible to undergo PCI on the target vessel

Exclusion Criteria:

  • Previous Q-wave myocardial infarction
  • Congestive heart failure with Left ventricular Ejection Fraction <35%
  • Confirmed pregnancy
  • Anemia to a hemoglobin level <8.5g/dl
  • Systemic mastocytosis
  • History of known haemorrhagic stroke at any time or any stroke less than or equal to 30 days prior to randomization
  • Severe hypertension (>180/110mmHG) not adequately controlled by antihypertensive therapy at time of study entry
  • Need for mechanical ventilation
  • Renal impairment: Creatinine > 1.6mg/dl
  • Known history of COPD with FEV 1s < 1.0 liter
  • Contra-indications to the use of adenosine, i.e.History of bronchospasm and/or ongoing therapy with theophylline derivatives, >1 degree atrioventricular block in the absence of a functioning electronic pacemaker and treatment with dipyridamole within the prior 24 hours
  • Patients with significant hemodynamic compromise and/or cardiogenic shock requiring inotropic or pressor support or pulmonary edema
  • History of or clinical documentation of severe aortic/mitral valve stenosis, significant aortic valve insufficiency
  • Participation in another trial with an investigational drug or device (of other investigations) including the follow-up period, within the last 30 days before enrollment
  • Inability or unwillingness to perform 30 day follow up
  • Concomitant disease that interferes with prognosis (life expectancy of less than or equal to 6 months
  • Contra-indications to standard drugs for coronary intervention and coronary heart disease: aspirin, heparin, low molecular weight heparin, clopidogrel, contrast dye
  • Patient weight > 110kg
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Germany,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00317512
Other Study ID Numbers  ICMJE COR-0001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biopure Corporation
Study Sponsor  ICMJE Biopure Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: P W Serruys, Professor University Medical Center Rotterdam
PRS Account Biopure Corporation
Verification Date May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP