Use of Hextend in Trauma

May 15, 2017 updated by: Kenneth Proctor, University of Miami
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1714

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Trauma patients

Description

Inclusion Criteria:

  • Admission to the trauma center

Exclusion Criteria:

  • Pregnant women, children, psychiatric patients and prisoners.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: Overall inpatient mortality upon discharge from the hospital with a mean length of stay of 8 days.
Overall inpatient mortality upon discharge from the hospital with a mean length of stay of 8 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Kenneth Proctor, PhD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

September 23, 2009

First Submitted That Met QC Criteria

September 23, 2009

First Posted (Estimate)

September 24, 2009

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20080598

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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