Coronary Artery DiseasePhase 2NCT00301535
A Study of Hemopure® to Enhance Tissue Preservation During Cardiopulmonary Bypass Surgery
A Phase 2 study testing HBOC-201 (hemoglobin glutamer-250 bovine) in people with Coronary Artery Disease, run by Biopure Corporation at 3 sites in 3 countries.
Trial summary
The purpose of this study is to determine if Hemopure® will enhance tissue preservation during Cardiopulmonary Bypass surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- HBOC-201 (hemoglobin glutamer-250 bovine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Feb 2006to Sep 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is between the ages of 18 and 80.
- Subject is an acceptable candidate for CABG.
- Subject is scheduled for CABG (without planned valvular repair or replacement) by cardiopulmonary bypass.
- Subject signs informed consent
- Subject and the treating physician agree that subject can comply with all study procedures and follow-up visit at time of subject screening.
Who cannot join
- Pre-operative myocardial infarction, defined as CK-MB level > 2 times upper limit of normal 24 hours prior to CABG surgery.
- Renal failure defined as serum creatinine greater 220 µmol/L
- Subject has an ejection fraction ≤ 30% (as measured by Echocardiography within 30 days of study enrollment).
- Active infection.
- History of prior stroke within last six months or history of prior stroke with residual neurological deficit.
- Transient Ischemic attack within last 6 months.
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- Subject has a history of coagulopathy.
- Subject is pregnant or currently breastfeeding.
- History of allergy to beef products.
- Pre-operative cardiogenic shock defined as cardiac index ≤ 1.8.L/min/m2 despite the use of vasopressors.
- Underlying medical conditions that would limit subject's life expectancy to less than 12 months.
- Severe pulmonary disease [based upon clinical diagnosis or pulmonary function tests (FEV <1 liter), if available] that may interfere with weaning subject from ventilator.
- History of acute central nervous disorder (e.g., seizure or traumatic injury).
- Severe hypertension (≥ 160/90 mm Hg) that cannot be medically controlled despite treatment with two antihypertensive therapies.
- Severe liver dysfunction as defined by total bilirubin ≥ 51 µmol/L or 2 times the site normal limit of AST or ALT activity.
- Subject has systemic mastocytosis.
- Subject has any condition that predisposes the subject to systemic mast cell degranulation or hypersensitivity reactions or a history of severe allergic reactions to drugs or environmental allergens.
- Subject has participated in another investigational drug, biologic or device study within 30 days prior to study enrollment.
Trial locations and contacts
3 sites in 3 countries.
Tiana Gorham contact
3 sites in 3 countries
Greece1 site, 1 recruiting
- Recruiting
Thessaloniki Heart Institute - St. Luke's Hospital
Thessaloniki, 552 36
Julia Tzelepi, MD, ktzelepipal@yahoo.gr
Antonis Pitsis, MD
South Africa1 site, 1 recruiting
- Recruiting
Milpark Hospital
Johannesburg
Ronel Snyman, research.jhb@mweb.co.za
Martin Sussman, MD
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford Heart Centre - John Radcliffe Hospital
Headington, Oxfordshire, OX3 9DU
Stephen Westaby, MD
About this study
Official title: Enhancement of Tissue Preservation During Cardiopulmonary Bypass With HBOC-201 (Registry Study)
The purpose of this study is to determine if Hemopure® will enhance tissue preservation during Cardiopulmonary Bypass surgery.
Read the detailed description
The primary objective is to determine the safety and feasibility of administering Hemopure® (HBOC-201) to reduce myocardial necrosis, as measured by CK-MB enzyme elevation, and enhance tissue preservation during cardiopulmonary bypass.
- Conditions
- Coronary Artery Disease
- Being tested
- HBOC-201 (hemoglobin glutamer-250 bovine)
- Keywords
- Coronary Artery Bypass Graft, memory loss after cardiac surgery, side effects of bypass
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBOC-201 (hemoglobin glutamer-250 bovine)Drug
HBOC-201 is an investigational solution of purified, glutaraldehyde-polymerized bovine hemoglobin with a concentration of hemoglobin of 13 ± 1 g/dL
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: HBOC-201 (hemoglobin glutamer-250 bovine) |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of peak CK-MB elevation ≥ 5X upper limit of normal
Measured: Baseline; Peri-op; Days 1,2,3 post procedure; Discharge or Day 6 post procedure(whichever is earlier)
Secondary outcomes (1)
MACE @ discharge and 30 days post surgery; Change in renal function; Renal failure; Increased Cardiac Troponin T; Death rate; MI/stroke; Supplemental RBC transfusions; Total units RBC and HBOC-201; Intra Aortic Balloon Pump use, pump time; New onset CHF
Measured: Duration of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2006 (estimated)
- Study startFeb 2006
- Primary completionJul 2008 (estimated)
- Study completionSep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biopure Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- A. Gerson Greenburg, MD, Ph.D, Study director, Biopure Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301535
- Sponsor's protocol ID
- BIOEU003
- Status last verified
- May 2008
- First submitted
- 9 Mar 2006
- Last updated
- 16 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement of Tissue Preservation During Cardiopulmonary Bypass With HBOC-201 (Registry Study)
- ClinicalTrials.gov ID
- NCT00301535
- Acronym / sponsor ID
- BIOEU003
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Bypass Graft, memory loss after cardiac surgery, side effects of bypass
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Biopure CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Jul 2008 (estimated)
- Study completion
- Sep 2008 (estimated)
- First posted
- 13 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if Hemopure® will enhance tissue preservation during Cardiopulmonary Bypass surgery.
Detailed description
The primary objective is to determine the safety and feasibility of administering Hemopure® (HBOC-201) to reduce myocardial necrosis, as measured by CK-MB enzyme elevation, and enhance tissue preservation during cardiopulmonary bypass.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: HBOC-201 (hemoglobin glutamer-250 bovine) |
| 2 | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is between the ages of 18 and 80.
- Subject is an acceptable candidate for CABG.
- Subject is scheduled for CABG (without planned valvular repair or replacement) by cardiopulmonary bypass.
- Subject signs informed consent
- Subject and the treating physician agree that subject can comply with all study procedures and follow-up visit at time of subject screening.
Key exclusion criteria (18 listed)
- Pre-operative myocardial infarction, defined as CK-MB level > 2 times upper limit of normal 24 hours prior to CABG surgery.
- Renal failure defined as serum creatinine greater 220 µmol/L
- Subject has an ejection fraction ≤ 30% (as measured by Echocardiography within 30 days of study enrollment).
- Active infection.
- History of prior stroke within last six months or history of prior stroke with residual neurological deficit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBOC-201 (hemoglobin glutamer-250 bovine)HBOC-201 is an investigational solution of purified, glutaraldehyde-polymerized bovine hemoglobin with a concentration of hemoglobin of 13 ± 1 g/dL | Drug | 1 |
Primary outcome
Rate of peak CK-MB elevation ≥ 5X upper limit of normal
Time frame: Baseline; Peri-op; Days 1,2,3 post procedure; Discharge or Day 6 post procedure(whichever is earlier)
1 secondary outcome
MACE @ discharge and 30 days post surgery; Change in renal function; Renal failure; Increased Cardiac Troponin T; Death rate; MI/stroke; Supplemental RBC transfusions; Total units RBC and HBOC-201; Intra Aortic Balloon Pump use, pump time; New onset CHF
Time frame: Duration of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiana Gorham contact
A. Gerson Greenburg, MD, Ph.D study director
Biopure Corporation
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HBOC-201 (hemoglobin glutamer-250 bovine) in people with Coronary Artery Disease, run by Biopure Corporation at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece, South Africa, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tiana Gorham (tgorham@biopure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of peak CK-MB elevation ≥ 5X upper limit of normal (time frame: Baseline; Peri-op; Days 1,2,3 post procedure; Discharge or Day 6 post procedure(whichever is earlier)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2008.