Wounds and InjuriesPhase 2NCT00301483
A Single Site Safety and Tolerability Study of HBOC-201 in Trauma Subjects
A Phase 2 study testing Hemoglobin-based oxygen carrier-201 (HBOC 201) in people with Wounds and Injuries, run by Biopure Corporation at 1 site in South Africa.
Trial summary
The main purpose of this study is to determine if HBOC-201 is safe and tolerable to trauma subjects, when given to treat the inadequate supply of blood and nutrients to tissues and organs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Hemoglobin-based oxygen carrier-201 (HBOC 201)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jul 2004to Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female (females not of childbearing potential or negative pregnancy test prior to enrollment)
- Age ≥ 18 years and ≤ 65 years of age
- Trauma with bleeding or a potential for bleeding arriving at initial treatment facility directly from scene of injury
- Subject should be enrolled within four (4) hours of injury
- Base Deficit (BD) greater than 5.0 and one of the following:
- Systolic Blood Pressure ≤ 100 mm Hg OR Sustained (≥ 10 minutes) Heart Rate ≥ 100
- No localized signs of traumatic brain injury and a Glasgow Coma Score of ≥9 with the exception of drug-induced lowered GCS.
- Informed consent, or independent physician authorization obtained
Who cannot join
- Known or suspected Traumatic Brain Injury
- Non-survivable injury (Falcone Criteria)
- Traumatic arrest
- Known prior cardiac arrest (i.e., preceding trauma episode)
- Known or suspected pregnancy
- Known allergy to bovine products
Show all 9Show fewer
- Prior treatment with blood (subsequent to current trauma)
- Informed consent or independent physician authorization unable to be obtained
- Unable to meet protocol or follow-up criteria
Trial locations and contacts
1 site in 1 country.
Tiana Gorham contact
South Africa1 site, 1 recruiting
- Recruiting
Department of Surgery: Johannesburg Hospital
Johannesburg, Gauteng
Ronel Snyman, 011 488 3943, research.jhb@mweb.co.za
Professor Ken D Boffard, MD
About this study
Official title: A Single-Center, Study to Evaluate the Safety and Tolerability of Hemoglobin-Based Oxygen Carrier-201 (HBOC 201) in Trauma Subjects. (Phase II - Safety and Tolerability)
The main purpose of this study is to determine if HBOC-201 is safe and tolerable to trauma subjects, when given to treat the inadequate supply of blood and nutrients to tissues and organs.
Read the detailed description
This Phase II study will be a single-center, randomized, single-blind, parallel-group, standard therapy-controlled, variable dose study of HBOC 201 administered to trauma subjects with bleeding or potential for bleeding who require standard fluid therapy for treatment of hypoperfusion. The type and incidence of adverse events and serious adverse events attributed to the study drug will be analyzed.
Secondary variables in this safety and tolerability study, will be summarized with descriptive statistics and frequency tables. The purpose of this data collection is to assess efficacy variables and the feasibility of utilizing these parameters in future trauma studies that will assess parameters of morbidity and mortality and include, but are not limited to:
- Time to improvement of serum (or plasma) lactate
- Time to improvement in the Base Deficit
- Time to maintained stability (BD<5) over 24 hours
- Overall improvement in Base Deficit over 24 Hours
- Stability of subjects at 24 hours
- Time to meet treatment-stopping criteria
- Volume to meet treatment-stopping criteria
- Incidence of infectious complications (e.g., incidence of ventilator-associated pneumonia)
- Length of time on ventilator
- Incidence of multiple organ dysfunction (MOD)
Hemorrhage with subsequent hypoperfusion is a major cause of both immediate and delayed death in subjects who have sustained traumatic injuries. Effective therapies for hemorrhage to treat hypoperfusion that can be given immediately following injury are lacking. The following issues confound this problem further:
- Hemorrhaging trauma victims often have an immediate need for therapy to ensure adequate delivery of oxygen to vital tissues;
- Standard of care fluids such as Lactated Ringers Solution do not provide oxygen and blood can not be readily stored, transported or easily used in pre-hospital settings
- In the absence of oxygen-carrying fluid, traditional approaches to sustain vital organ perfusion, such as administration of intravenous fluid therapy, may have detrimental effects if given prior to hemostasis in certain subjects, particularly those with penetrating truncal injuries.
- Conditions
- Wounds and Injuries
- Being tested
- Hemoglobin-based oxygen carrier-201 (HBOC 201), Standard of Care
- Keywords
- multiple trauma, bleeding injuries, gunshot wounds, stab wounds, penetrating injuries, blunt trauma, multiple wounds
- Medical subject headings
- Wounds and Injuries, Multiple Trauma, Wounds, Gunshot, Wounds, Stab, Wounds, Nonpenetrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemoglobin-based oxygen carrier-201 (HBOC 201)Drug
HBOC-201 is an investigational solution of sterile, ultrapurified, glutaraldehyde polymerized, modified bovine hemoglobin (Hb) in a balanced electrolyte solution. HBOC-201 has an Hb concentration of 12-14g/dL. HBOC-201 is an isosmotic solution that is stable for at least 36 months at 2-30ºC. It requires no reconstitution and can be administered directly into a peripheral or central vein. Blood typing is not required because all other cellular components, including the RBC membranes that carry the blood group antigens, have been removed.
Standard of CareOther
Standard Therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | HBOC-201 followed by standard therapy Receives: Drug: Hemoglobin-based oxygen carrier-201 (HBOC 201) |
| 2 | Active comparator | Standard Therapy Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/Tolerability of HBOC-201 for treatment of hypoperfusion in trauma by analysis of AEs/SAEs attributed to study drug
Measured: Duration of the study (Randomization through 28-day follow-up)
Secondary outcomes (1)
Efficacy/feasibility of the following measurements in trauma studies (list is not all inclusive): Time to serum lactate improvement, Base deficit (BD) improvement, BD > 5 over 24 hrs, 24 hr stability, Infection, Vent time
Measured: Duration of the study (Randomization through 28-day follow-up)
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 startJul 2004
- Primary completionSep 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biopure Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- A. Gerson Greenburg, MD, PhD, Study director, Biopure CorporationProfessor Ken D Boffard, MD, Principal investigator, Wits University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301483
- Sponsor's protocol ID
- HEM-0125
- Status last verified
- Feb 2008
- First submitted
- 10 Mar 2006
- Last updated
- 6 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Study to Evaluate the Safety and Tolerability of Hemoglobin-Based Oxygen Carrier-201 (HBOC 201) in Trauma Subjects. (Phase II - Safety and Tolerability)
- ClinicalTrials.gov ID
- NCT00301483
- Acronym / sponsor ID
- HEM-0125
- Conditions
- Wounds and Injuries
- Keywords
- multiple trauma, bleeding injuries, gunshot wounds, stab wounds, penetrating injuries, blunt trauma, multiple wounds
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Biopure CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Sep 2008 (estimated)
- Study completion
- Dec 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 main purpose of this study is to determine if HBOC-201 is safe and tolerable to trauma subjects, when given to treat the inadequate supply of blood and nutrients to tissues and organs.
Detailed description
This Phase II study will be a single-center, randomized, single-blind, parallel-group, standard therapy-controlled, variable dose study of HBOC 201 administered to trauma subjects with bleeding or potential for bleeding who require standard fluid therapy for treatment of hypoperfusion. The type and incidence of adverse events and serious adverse events attributed to the study drug will be analyzed.
Secondary variables in this safety and tolerability study, will be summarized with descriptive statistics and frequency tables. The purpose of this data collection is to assess efficacy variables and the feasibility of utilizing these parameters in future trauma studies that will assess parameters of morbidity and mortality and include, but are not limited to:
- Time to improvement of serum (or plasma) lactate
- Time to improvement in the Base Deficit
- Time to maintained stability (BD<5) over 24 hours
- Overall improvement in Base Deficit over 24 Hours
- Stability of subjects at 24 hours
- Time to meet treatment-stopping criteria
- Volume to meet treatment-stopping criteria
- Incidence of infectious complications (e.g., incidence of ventilator-associated pneumonia)
- Length of time on ventilator
- Incidence of multiple organ dysfunction (MOD)
Hemorrhage with subsequent hypoperfusion is a major cause of both immediate and delayed death in subjects who have sustained traumatic injuries. Effective therapies for hemorrhage to treat hypoperfusion that can be given immediately following injury are lacking. The following issues confound this problem further:
- Hemorrhaging trauma victims often have an immediate need for therapy to ensure adequate delivery of oxygen to vital tissues;
- Standard of care fluids such as Lactated Ringers Solution do not provide oxygen and blood can not be readily stored, transported or easily used in pre-hospital settings
- In the absence of oxygen-carrying fluid, traditional approaches to sustain vital organ perfusion, such as administration of intravenous fluid therapy, may have detrimental effects if given prior to hemostasis in certain subjects, particularly those with penetrating truncal injuries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Hemoglobin-based oxygen carrier-201 (HBOC 201)HBOC-201 followed by standard therapy |
| 2 | Active comparator | Other: Standard of CareStandard Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or Female (females not of childbearing potential or negative pregnancy test prior to enrollment)
- Age ≥ 18 years and ≤ 65 years of age
- Trauma with bleeding or a potential for bleeding arriving at initial treatment facility directly from scene of injury
- Subject should be enrolled within four (4) hours of injury
- Base Deficit (BD) greater than 5.0 and one of the following:
Key exclusion criteria (9 listed)
- Known or suspected Traumatic Brain Injury
- Non-survivable injury (Falcone Criteria)
- Traumatic arrest
- Known prior cardiac arrest (i.e., preceding trauma episode)
- Known or suspected pregnancy
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 |
|---|---|---|
| Hemoglobin-based oxygen carrier-201 (HBOC 201)HBOC-201 is an investigational solution of sterile, ultrapurified, glutaraldehyde polymerized, modified bovine hemoglobin (Hb) in a balanced electrolyte solution. HBOC-201 has an Hb concentration of 12-14g/dL. HBOC-201 is an isosmotic solution that is stable for at least 36 months at 2-30ºC. It requires no reconstitution and can be administered directly into a peripheral or central vein. Blood typing is not required because all other cellular components, including the RBC membranes that carry the blood group antigens, have been removed. | Drug | 1 |
| Standard of CareStandard Therapy | Other | 2 |
Primary outcome
Safety/Tolerability of HBOC-201 for treatment of hypoperfusion in trauma by analysis of AEs/SAEs attributed to study drug
Time frame: Duration of the study (Randomization through 28-day follow-up)
1 secondary outcome
Efficacy/feasibility of the following measurements in trauma studies (list is not all inclusive): Time to serum lactate improvement, Base deficit (BD) improvement, BD > 5 over 24 hrs, 24 hr stability, Infection, Vent time
Time frame: Duration of the study (Randomization through 28-day follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 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, PhD study director
Biopure Corporation
Professor Ken D Boffard, MD principal investigator
Wits University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hemoglobin-based oxygen carrier-201 (HBOC 201) in people with Wounds and Injuries, run by Biopure Corporation at 1 site in South Africa.
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 8 inclusion and 9 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 6 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. 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?
Safety/Tolerability of HBOC-201 for treatment of hypoperfusion in trauma by analysis of AEs/SAEs attributed to study drug (time frame: Duration of the study (Randomization through 28-day follow-up)). 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 6 Mar 2008.