Pilot Study of Hemoglobin Based Oxygen Therapeutics in Elective Coronary Revascularization
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
1 other identifier
interventional
45
3 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2003
Typical duration for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 21, 2006
CompletedFirst Posted
Study publicly available on registry
April 25, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedMay 16, 2008
May 1, 2008
1.3 years
April 21, 2006
May 15, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (13)
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
Study Arms (3)
1
ACTIVE COMPARATORVoluven will be administered at 7.7 ml/min over 15 minutes,followed by Voluven at 7.7 ml/min over 15 minutes
2
ACTIVE COMPARATORHBOC-201 will be administered at 7.7 ml/min over 15 minutes,followed by Voluven at 7.7 ml/min over 15 minutes
3
EXPERIMENTALHBOC-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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
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
Related Publications (1)
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.
PMID: 19608488RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
P W Serruys, Professor
University Medical Center Rotterdam
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 21, 2006
First Posted
April 25, 2006
Study Start
December 1, 2003
Primary Completion
April 1, 2005
Study Completion
July 1, 2007
Last Updated
May 16, 2008
Record last verified: 2008-05