NCT00588796

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2005

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

December 25, 2007

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 9, 2008

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

8.9 years

First QC Date

December 25, 2007

Last Update Submit

February 2, 2015

Conditions

Burn InjuryMajor Trauma

Keywords

fibrinogenburnstraumametabolism

Outcome Measures

Primary Outcomes (1)

  • During the flow phase following burn or trauma injury, fibrinogen degradation is accelerated

    7

Secondary Outcomes (1)

  • Fibrinogen degradation stimulates fibrinogen synthesis at the expense of whole body protein catabolism

    7 days

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Burn patients Trauma patients Healthy Volunteers

You may qualify if:

  • % total body surface area burn or more
  • severe trauma with injury severity score greater than 10
  • between ages of 18 and 65 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 660699BACKGROUND

MeSH Terms

Conditions

BurnsWounds and Injuries

Study Officials

  • Wenjun Z Martini, PhD

    United States Army Institute of Surgical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2007

First Posted

January 9, 2008

Study Start

February 1, 2005

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

February 4, 2015

Record last verified: 2015-02