search
Back to results

Pilot Study of Hemoglobin Based Oxygen Therapeutics in Elective Coronary Revascularization

Primary Purpose

Angina Pectoris, Unstable Angina, Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Percutaneous Coronary Revascularization
Hemoglobin-Based Oxygen Carrier-201 (HBOC-201)
Voluven
Sponsored by
Biopure Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angina Pectoris focused on measuring Hemoglobin Based Oxygen carrier, HBOC 201, Percutaneous Revascularization, Percutaneous Coronary Intervention, Non ST-segment Elevation Myocardial Infarction, Tissue Oxygenation, Transluminal Percutaneous Coronary Angioplasty

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site # 5 Onze Lieve Vrouw Ziekenhuis (OLVZ)
  • Site # 6 Antwerpen
  • Site # 2 Herzzentrum
  • Site # 3 OLVG Amsterdam
  • Site # 4 Academisch Medisch Centrum (AMC)
  • Site # 1 Erasmus Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

1

2

3

Arm Description

Voluven will be administered at 7.7 ml/min over 15 minutes,followed by Voluven at 7.7 ml/min over 15 minutes

HBOC-201 will be administered at 7.7 ml/min over 15 minutes,followed by Voluven at 7.7 ml/min over 15 minutes

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 21, 2006
Last Updated
May 15, 2008
Sponsor
Biopure Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT00317512
Brief Title
Pilot Study of Hemoglobin Based Oxygen Therapeutics in Elective Coronary Revascularization
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Biopure Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris, Unstable Angina, Myocardial Infarction
Keywords
Hemoglobin Based Oxygen carrier, HBOC 201, Percutaneous Revascularization, Percutaneous Coronary Intervention, Non ST-segment Elevation Myocardial Infarction, Tissue Oxygenation, Transluminal Percutaneous Coronary Angioplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Voluven will be administered at 7.7 ml/min over 15 minutes,followed by Voluven at 7.7 ml/min over 15 minutes
Arm Title
2
Arm Type
Active Comparator
Arm Description
HBOC-201 will be administered at 7.7 ml/min over 15 minutes,followed by Voluven at 7.7 ml/min over 15 minutes
Arm Title
3
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Coronary Revascularization
Intervention Type
Drug
Intervention Name(s)
Hemoglobin-Based Oxygen Carrier-201 (HBOC-201)
Intervention Type
Drug
Intervention Name(s)
Voluven
Primary Outcome Measure Information:
Title
Safety
Title
In hospital thrombotic events
Title
Anaphylactic reactions
Title
Inflammatory reactions
Title
Substantial changes to systemic & coronary hemodynamics
Title
Circulatory overload
Title
Renal dysfunction
Title
Untoward drug interaction effects
Title
substantial changes in laboratory parameters
Title
Life threatening cardiac arrhythmias
Title
Other adverse events
Title
Feasibility:
Title
Number of subjects requiring premature discontinuation of study drug for clinical or logistical reasons

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P W Serruys, Professor
Organizational Affiliation
University Medical Center Rotterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
Site # 5 Onze Lieve Vrouw Ziekenhuis (OLVZ)
City
Aalst
Country
Belgium
Facility Name
Site # 6 Antwerpen
City
Antwerpen
Country
Belgium
Facility Name
Site # 2 Herzzentrum
City
Leipzig
Country
Germany
Facility Name
Site # 3 OLVG Amsterdam
City
Amsterdam
Country
Netherlands
Facility Name
Site # 4 Academisch Medisch Centrum (AMC)
City
Amsterdam
Country
Netherlands
Facility Name
Site # 1 Erasmus Medical Center
City
Rotterdam
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
19608488
Citation
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.
Results Reference
result

Learn more about this trial

Pilot Study of Hemoglobin Based Oxygen Therapeutics in Elective Coronary Revascularization

We'll reach out to this number within 24 hrs