Pilot Study of Hemoglobin Based Oxygen Therapeutics in Elective Coronary Revascularization

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biopure Corporation
• Treatments: HBOC 201

Criteria

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