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Use of Hextend in Trauma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00983281
Recruitment Status : Completed
First Posted : September 24, 2009
Results First Posted : February 18, 2013
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Kenneth Proctor, University of Miami

Brief Summary:
This is a chart review of all trauma patients during the specified time period. The purpose of this study is to examine the effects of resuscitation with hextend after trauma, in the adult population. The authors hypothesize that when compared to patients resuscitated with standard of care, resuscitation with Hextend will result in a mortality difference.

Condition or disease Intervention/treatment
Trauma Drug: Hextend

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Study Type : Observational
Actual Enrollment : 1714 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Use of Hextend in Trauma
Study Start Date : August 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Hextend

Group/Cohort Intervention/treatment
Hextend
Patients that received Hextend as part of their fluid resuscitation.
Drug: Hextend
IV fluid resuscitation to restore euvolemia after traumatic injury and surgery.

Standard of Care
Patients that received standard fluid resuscitation but no Hextend.
Drug: Hextend
IV fluid resuscitation to restore euvolemia after traumatic injury and surgery.




Primary Outcome Measures :
  1. Mortality [ Time Frame: Overall inpatient mortality upon discharge from the hospital with a mean length of stay of 8 days. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Trauma patients
Criteria

Inclusion Criteria:

  • Admission to the trauma center

Exclusion Criteria:

  • Pregnant women, children, psychiatric patients and prisoners.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00983281


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Kenneth Proctor, PhD University of Miami
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Responsible Party: Kenneth Proctor, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT00983281    
Other Study ID Numbers: 20080598
First Posted: September 24, 2009    Key Record Dates
Results First Posted: February 18, 2013
Last Update Posted: June 14, 2017
Last Verified: February 2013
Keywords provided by Kenneth Proctor, University of Miami:
Combat casualty care
Hextend
Colloid
Additional relevant MeSH terms:
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Wounds and Injuries