Traumatic HemorrhageNCT00328133
The Use of rFVIIa in Trauma Patients: A Multi-Center Case Registry
An observational study of Traumatic Hemorrhage and Hemorrhagic Shock, run by University of California, San Francisco at 1 site in United States.
Trial summary
Trauma surgeons throughout the US have begun using recombinant activated factor VII (rFVIIa) to control severe hemorrhage following injury when traditional measures have failed. Despite promising results from several small studies, there remain several unanswered questions regarding the use of this relatively… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Hemorrhage, Hemorrhagic Shock
- How many people
- 380 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jun 2011
- Phase
- Observational
- 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
Study population: Retrospective and prospective observational case review study on traumatically injured adult patients.
Who may be able to join
- Coagulopathy treated with rFVIIa
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco, San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: The Use of rFVIIa in Trauma Patients: A WTA/AAST Multi-Center Case Registry
Trauma surgeons throughout the US have begun using recombinant activated factor VII (rFVIIa) to control severe hemorrhage following injury when traditional measures have failed. Despite promising results from several small studies, there remain several unanswered questions regarding the use of this relatively expensive product in injured patients including:
- The timing of administration
- Selection of appropriate patients who are most likely to benefit
- The effective dose in injured patients
- The potential need for repeated dosing
- The need for administration of platelets and correction of acidosis prior to administering the first dose
- The risks associated with the use of rFVIIa including venous and/or arterial thrombosis
- The potential for rFVIIa to cause or aggravate post-injury organ failure and/or infectious complications
- An analysis of cost versus benefit The purpose of this study is to collect a large sample of patients from multiple institutions in order to address the issues listed above. To this end, the Western Trauma Association Foundation is sponsoring a multi-center case registry for patients receiving rFVIIa for treatment of uncontrolled hemorrhage.
Read the detailed description
This is a prospective, multi-center case registry that seeks to combine the collective experience with the use of rFVIIa at UCSF/SFGH with other trauma centers. The study is being conducted under the auspices of the Western Trauma Association and the American Association of the Surgery of Trauma. Both organizations have a long history of successfully completing multi-center studies. The outcomes to be used in this study are: 1) survival, 2) amount of blood products infused before and after rFVIIa, 3) coagulation factors (PTT, INR) before and after, and 4) the surgeon's assessment of hemostasis. Data will also be analyzed to determine the cost effectiveness of rFVIIa when compared with other methods of treating severe hemorrhage, primarily administration of blood products. Finally, the incidence of complications and thrombotic events after drug administration will be evaluated.
- Conditions
- Traumatic Hemorrhage, Hemorrhagic Shock
- Keywords
- recombinant Factor VIIa, traumatic hemorrhage, hemorrhagic shock, coagulopathy
- Medical subject headings
- Shock, Hemorrhagic, Hemostatic Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startJun 2006
- Primary completionJun 2010
- Study completionJun 2011
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 Traumatic HemorrhageStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Western Trauma Association, Novo Nordisk A/S, American Association for the Surgery of Trauma
- Responsible party
- Sponsor
- Investigators
- Margaret Knudson, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328133
- Sponsor's protocol ID
- H6693-27309-01
- Status last verified
- May 2012
- First submitted
- 17 May 2006
- Last updated
- 10 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Knudson MM, Cohen MJ, Reidy R, Jaeger S, Bacchetti P, Jin C, Wade CE, Holcomb JB. Trauma, transfusions, and use of recombinant factor VIIa: A multicenter case registry report of 380 patients from the Western Trauma Association. J Am Coll Surg. 2011 Jan;212(1):87-95. doi: 10.1016/j.jamcollsurg.2010.08.020. Epub 2010 Nov 5.
PubMed 21115374
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of rFVIIa in Trauma Patients: A WTA/AAST Multi-Center Case Registry
- ClinicalTrials.gov ID
- NCT00328133
- Acronym / sponsor ID
- H6693-27309-01
- Conditions
- Traumatic Hemorrhage, Hemorrhagic Shock
- Keywords
- recombinant Factor VIIa, traumatic hemorrhage, hemorrhagic shock, coagulopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Western Trauma Association, Novo Nordisk A/S, American Association for the Surgery of Trauma
- Study start
- Jun 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 19 May 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.
Trauma surgeons throughout the US have begun using recombinant activated factor VII (rFVIIa) to control severe hemorrhage following injury when traditional measures have failed. Despite promising results from several small studies, there remain several unanswered questions regarding the use of this relatively expensive product in injured patients including:
- The timing of administration
- Selection of appropriate patients who are most likely to benefit
- The effective dose in injured patients
- The potential need for repeated dosing
- The need for administration of platelets and correction of acidosis prior to administering the first dose
- The risks associated with the use of rFVIIa including venous and/or arterial thrombosis
- The potential for rFVIIa to cause or aggravate post-injury organ failure and/or infectious complications
- An analysis of cost versus benefit The purpose of this study is to collect a large sample of patients from multiple institutions in order to address the issues listed above. To this end, the Western Trauma Association Foundation is sponsoring a multi-center case registry for patients receiving rFVIIa for treatment of uncontrolled hemorrhage.
Detailed description
This is a prospective, multi-center case registry that seeks to combine the collective experience with the use of rFVIIa at UCSF/SFGH with other trauma centers. The study is being conducted under the auspices of the Western Trauma Association and the American Association of the Surgery of Trauma. Both organizations have a long history of successfully completing multi-center studies. The outcomes to be used in this study are: 1) survival, 2) amount of blood products infused before and after rFVIIa, 3) coagulation factors (PTT, INR) before and after, and 4) the surgeon's assessment of hemostasis. Data will also be analyzed to determine the cost effectiveness of rFVIIa when compared with other methods of treating severe hemorrhage, primarily administration of blood products. Finally, the incidence of complications and thrombotic events after drug administration will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective and prospective observational case review study on traumatically injured adult patients.
Key inclusion criteria (1 listed)
- Coagulopathy treated with rFVIIa
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2012.
- Results publication: PubMed 21115374Knudson MM, Cohen MJ, Reidy R, Jaeger S, Bacchetti P, Jin C, Wade CE, Holcomb JB. Trauma, transfusions, and use of recombinant factor VIIa: A multicenter case registry report of 380 patients from the Western Trauma Association. J Am Coll Surg. 2011 Jan;212(1):87-95. doi: 10.1016/j.jamcollsurg.2010.08.020. Epub 2010 Nov 5.
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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.
Margaret Knudson, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Hemorrhage and Hemorrhagic Shock, run by University of California, San Francisco at 1 site 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 1 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: finished, as of the sponsor's last update on 10 May 2012. 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 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 NCT00328133, 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 10 May 2012.