Pilot Study of Hemoglobin Based Oxygen Therapeutics in Elective Coronary Revascularization
NCT ID: NCT00317512
Last Updated: 2008-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
45 participants
INTERVENTIONAL
2003-12-31
2007-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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1
Voluven will be administered at 7.7 ml/min over 15 minutes,followed by Voluven at 7.7 ml/min over 15 minutes
Percutaneous Coronary Revascularization
Voluven
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
Percutaneous Coronary Revascularization
Hemoglobin-Based Oxygen Carrier-201 (HBOC-201)
Voluven
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
Percutaneous Coronary Revascularization
Hemoglobin-Based Oxygen Carrier-201 (HBOC-201)
Interventions
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Percutaneous Coronary Revascularization
Hemoglobin-Based Oxygen Carrier-201 (HBOC-201)
Voluven
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Biopure Corporation
INDUSTRY
Responsible Party
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Biopure Corporation
Principal Investigators
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P W Serruys, Professor
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Rotterdam
Locations
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Site # 5 Onze Lieve Vrouw Ziekenhuis (OLVZ)
Aalst, , Belgium
Site # 6 Antwerpen
Antwerp, , Belgium
Site # 2 Herzzentrum
Leipzig, , Germany
Site # 3 OLVG Amsterdam
Amsterdam, , Netherlands
Site # 4 Academisch Medisch Centrum (AMC)
Amsterdam, , Netherlands
Site # 1 Erasmus Medical Center
Rotterdam, , Netherlands
Countries
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References
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Serruys PW, Vranckx P, Slagboom T, Regar E, Meliga E, de Winter RJ, Heyndrickx G, Schuler G, van Remortel EA, Dube 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. doi: 10.4244/eijv3i5a108.
Other Identifiers
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COR-0001
Identifier Type: -
Identifier Source: org_study_id