Burn InjuryNCT00588796
Study of Fibrinogen Metabolism During Severe Trauma and Burns
An observational study of Burn Injury and Major Trauma, run by United States Army Institute of Surgical Research.
Trial summary
To study the fibrinogen metabolic changes in relation to coagulation disorder in patients with severe burns and trauma injuries. As a result of the burn or trauma injury breakdown of fibrinogen is accelerated. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Burn Injury, Major Trauma
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2005to Jan 2014
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Burn patients Trauma patients Healthy Volunteers
Who may be able to join
- 20% total body surface area burn or more
- severe trauma with injury severity score greater than 10
- between ages of 18 and 65 years
Who cannot join
- history of blood clotting disorder
- history of liver disease such as cirrhosis or hepatitis
- pregnant or nursing
- allergic to iodine, shellfish or dye used in X-Rays
- taking long term medications for blood clotting usch as Coumadin or Plavix
- prisoners
- receiving total parenteral nutrition
About this study
Official title: Alteration in Fibrinogen Metabolism in Patients With Severe Burns and Traumatic Injuries
To study the fibrinogen metabolic changes in relation to coagulation disorder in patients with severe burns and trauma injuries. As a result of the burn or trauma injury breakdown of fibrinogen is accelerated.
Read the detailed description
In this protocol, we will investigate fibrinogen metabolism in burn and trauma patients, using an 8h infusion of stable isotopes labeled amino acids (1-13C-phenylalanine, 2H5-phenylalanine, and 2H3-ketoisocaporate). The increase of the labeled amino acids incorporating into fibrinogen during the infusion and the decay of labeled fibrinogen after stopping the isotopes infusion (as measured by GC-MS) will be used to calculate fibrinogen synthesis and degradation. Stable isotopes are non-radioactive.
- Conditions
- Burn Injury, Major Trauma
- Keywords
- fibrinogen, burns, trauma, metabolism
- Medical subject headings
- Burns, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Healthy Volunteers | |
| Burn patients | Patients who have sustained burn injury greater than or equal to 20% of total body surface area | |
| Trauma patients | Patients who have undergone trauma |
What is being measured
The primary outcome is the main question the study is designed to answer.
During the flow phase following burn or trauma injury, fibrinogen degradation is accelerated
Measured: 7
Secondary outcomes (1)
Fibrinogen degradation stimulates fibrinogen synthesis at the expense of whole body protein catabolism
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2008 (estimated)
- Study startFeb 2005
- Primary completionJan 2014
- Study completionJan 2014
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 Burn InjuryStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Institute of Surgical Research
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Wenjun Z Martini, PhD, Principal investigator, United States Army Institute of Surgical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588796
- Sponsor's protocol ID
- H-04-017
- Status last verified
- Feb 2015
- First submitted
- 25 Dec 2007
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Zuckerman L, Caprini JA, Lipp V, Vagher JP. Disseminated intravascular multiple systems activation (DIMSA) following thermal injury. J Trauma. 1978 Jun;18(6):432-9. doi: 10.1097/00005373-197806000-00008.
PubMed 660699
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alteration in Fibrinogen Metabolism in Patients With Severe Burns and Traumatic Injuries
- ClinicalTrials.gov ID
- NCT00588796
- Acronym / sponsor ID
- H-04-017
- Conditions
- Burn Injury, Major Trauma
- Keywords
- fibrinogen, burns, trauma, metabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- United States Army Institute of Surgical ResearchUS federal agency
- Study start
- Feb 2005
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 9 Jan 2008 (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.
To study the fibrinogen metabolic changes in relation to coagulation disorder in patients with severe burns and trauma injuries. As a result of the burn or trauma injury breakdown of fibrinogen is accelerated.
Detailed description
In this protocol, we will investigate fibrinogen metabolism in burn and trauma patients, using an 8h infusion of stable isotopes labeled amino acids (1-13C-phenylalanine, 2H5-phenylalanine, and 2H3-ketoisocaporate). The increase of the labeled amino acids incorporating into fibrinogen during the infusion and the decay of labeled fibrinogen after stopping the isotopes infusion (as measured by GC-MS) will be used to calculate fibrinogen synthesis and degradation. Stable isotopes are non-radioactive.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Healthy Volunteers |
| Burn patients | – | –Patients who have sustained burn injury greater than or equal to 20% of total body surface area |
| Trauma patients | – | –Patients who have undergone trauma |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Burn patients Trauma patients Healthy Volunteers
Key inclusion criteria (3 listed)
- 20% total body surface area burn or more
- severe trauma with injury severity score greater than 10
- between ages of 18 and 65 years
Key exclusion criteria (7 listed)
- history of blood clotting disorder
- history of liver disease such as cirrhosis or hepatitis
- pregnant or nursing
- allergic to iodine, shellfish or dye used in X-Rays
- taking long term medications for blood clotting usch as Coumadin or Plavix
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
During the flow phase following burn or trauma injury, fibrinogen degradation is accelerated
Time frame: 7
1 secondary outcome
Fibrinogen degradation stimulates fibrinogen synthesis at the expense of whole body protein catabolism
Time frame: 7 days
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 4 Feb 2015.
- Background: PubMed 660699Zuckerman L, Caprini JA, Lipp V, Vagher JP. Disseminated intravascular multiple systems activation (DIMSA) following thermal injury. J Trauma. 1978 Jun;18(6):432-9. doi: 10.1097/00005373-197806000-00008.
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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.
Wenjun Z Martini, PhD principal investigator
United States Army Institute of Surgical Research
Questions about this trial
What is this clinical trial studying?
An observational study of Burn Injury and Major Trauma, run by United States Army Institute of Surgical Research.
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 3 inclusion and 7 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 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
During the flow phase following burn or trauma injury, fibrinogen degradation is accelerated (time frame: 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00588796, 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 4 Feb 2015.