Hemorrhagic ShockPhase 3NCT00076648
Safety and Efficacy of PolyHeme(R) in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Pre-Hospital Setting
A Phase 3 study testing Poly SFH-P Injection in people with Hemorrhagic Shock, run by Northfield Laboratories at 32 sites in United States.
Trial summary
This study is designed to assess the survival benefit of administering PolyHeme to severely injured trauma patients in hemorrhagic shock beginning in the prehospital setting, where blood is not available, and continuing throughout a 12-hour postinjury hospital setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhagic Shock
- What is being tested?
- Poly SFH-P Injection
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 32 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients following trauma who have sustained blood loss and are in shock
Who cannot join
- Patients who have sustained unsurvivable injuries
- Patients who have severe head injury
- Pregnant females
- Patients found in cardiac arrest
- Patients who object to participation (e.g., religious grounds, wearing exclusion bracelet).
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Albany Medical Center
Albany, New York, 12208
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
St. Luke's Regional Resource Trauma Center
Bethlehem, Pennsylvania, 18015
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267-0769
MetroHealth Medical Center
Cleveland, Ohio, 44109
Miami Valley Hospital
Dayton, Ohio, 45409
Denver Health Medical Center
Denver, Colorado, 80204
Detroit Receiving Hospital
Detroit, Michigan, 48201
Sinai Grace Hospital
Detroit, Michigan, 48201
Duke University Medical Center
Durham, North Carolina, 27710
Inova Fairfax Hospital
Falls Church, Virginia, 22066
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6315
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Memorial-Hermann Hospital
Houston, Texas, 77030
Methodist Hospital of Indiana
Indianapolis, Indiana, 46202
Wishard Memorial Hospital
Indianapolis, Indiana, 46202
Johnson City Medical Center
Johnson City, Tennessee, 37604
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Kentucky Medical Center
Lexington, Kentucky, 40536
Medical Center of Central Georgia
Macon, Georgia, 31201
Loyola University Medical Center
Maywood, Illinois, 60153
University of Tennessee-Memphis
Memphis, Tennessee, 38163
West Virginia University/Jon Michael Moore Trauma Center
Morgantown, West Virginia, 26506
Christiana Hospital
Newark, Delaware, 19718
Sentara Norfolk Hospital
Norfolk, Virginia, 23507
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298-0454
The Mayo Clinic
Rochester, Minnesota, 55905
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
LDS Hospital
Salt Lake City, Utah, 84143
University of Texas Health Science Center
San Antonio, Texas, 78284
Scripps Mercy
San Diego, California, 92103
UC San Diego Medical Center
San Diego, California, 92103
About this study
Official title: A Phase III, Randomized, Controlled, Open-Label, Multicenter, Parallel Group Study Using Provisions for Exception From Informed Consent Requirements Designed to Evaluate the Safety and Efficacy of Poly SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme(R)] When Used to Treat Patients in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Prehospital Setting
This study is designed to assess the survival benefit of administering PolyHeme to severely injured trauma patients in hemorrhagic shock beginning in the prehospital setting, where blood is not available, and continuing throughout a 12-hour postinjury hospital setting.
- Conditions
- Hemorrhagic Shock
- Being tested
- Poly SFH-P Injection
- Medical subject headings
- Shock, Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly SFH-P InjectionDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2004 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemorrhagic ShockStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Northfield Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00076648
- Sponsor's protocol ID
- RTBSE-11-(N)
- Status last verified
- Jul 2006
- First submitted
- 28 Jan 2004
- Last updated
- 2 Aug 2006
- Results posted
- No
Publications
Moore EE, Moore FA, Fabian TC, Bernard AC, Fulda GJ, Hoyt DB, Duane TM, Weireter LJ Jr, Gomez GA, Cipolle MD, Rodman GH Jr, Malangoni MA, Hides GA, Omert LA, Gould SA; PolyHeme Study Group. Human polymerized hemoglobin for the treatment of hemorrhagic shock when blood is unavailable: the USA multicenter trial. J Am Coll Surg. 2009 Jan;208(1):1-13. doi: 10.1016/j.jamcollsurg.2008.09.023. Epub 2008 Nov 7.
PubMed 19228496
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Controlled, Open-Label, Multicenter, Parallel Group Study Using Provisions for Exception From Informed Consent Requirements Designed to Evaluate the Safety and Efficacy of Poly SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme(R)] When Used to Treat Patients in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Prehospital Setting
- ClinicalTrials.gov ID
- NCT00076648
- Acronym / sponsor ID
- RTBSE-11-(N)
- Conditions
- Hemorrhagic Shock
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Northfield LaboratoriesIndustry (pharma, biotech, devices)
- First posted
- 30 Jan 2004 (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.
This study is designed to assess the survival benefit of administering PolyHeme to severely injured trauma patients in hemorrhagic shock beginning in the prehospital setting, where blood is not available, and continuing throughout a 12-hour postinjury hospital setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients following trauma who have sustained blood loss and are in shock
Key exclusion criteria (5 listed)
- Patients who have sustained unsurvivable injuries
- Patients who have severe head injury
- Pregnant females
- Patients found in cardiac arrest
- Patients who object to participation (e.g., religious grounds, wearing exclusion bracelet).
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 |
|---|---|---|
| Poly SFH-P Injection | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2006.
- Derived from this study: PubMed 19228496Moore EE, Moore FA, Fabian TC, Bernard AC, Fulda GJ, Hoyt DB, Duane TM, Weireter LJ Jr, Gomez GA, Cipolle MD, Rodman GH Jr, Malangoni MA, Hides GA, Omert LA, Gould SA; PolyHeme Study Group. Human polymerized hemoglobin for the treatment of hemorrhagic shock when blood is unavailable: the USA multicenter trial. J Am Coll Surg. 2009 Jan;208(1):1-13. doi: 10.1016/j.jamcollsurg.2008.09.023. Epub 2008 Nov 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Poly SFH-P Injection in people with Hemorrhagic Shock, run by Northfield Laboratories at 32 sites in United States.
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 1 inclusion and 5 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 2 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00076648, which also lists 1 linked publication.
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 2 Aug 2006.