NCT00983281

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,714

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2009

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

February 18, 2013

Completed
Last Updated

June 14, 2017

Status Verified

February 1, 2013

Enrollment Period

1.1 years

First QC Date

September 23, 2009

Results QC Date

January 15, 2013

Last Update Submit

May 15, 2017

Conditions

Trauma

Keywords

Combat casualty careHextendColloid

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Overall inpatient mortality upon discharge from the hospital with a mean length of stay of 8 days.

Study Arms (2)

Hextend

Patients that received Hextend as part of their fluid resuscitation.

Drug: Hextend

Standard of Care

Patients that received standard fluid resuscitation but no Hextend.

Drug: Hextend

Interventions

HextendDRUG

IV fluid resuscitation to restore euvolemia after traumatic injury and surgery.

HextendStandard of Care

Eligibility Criteria

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

Trauma patients

You may qualify if:

  • Admission to the trauma center

You may not qualify if:

  • Pregnant women, children, psychiatric patients and prisoners.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Hydroxyethyl Starch Derivatives

Intervention Hierarchy (Ancestors)

StarchDietary CarbohydratesCarbohydratesGlucansPolysaccharides

Results Point of Contact

Title
Kenneth Proctor, PhD
Organization
University of Miami
kproctor@med.miami.edu
305-243-4694

Study Officials

  • Kenneth Proctor, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 23, 2009

First Posted

September 24, 2009

Study Start

August 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

June 14, 2017

Results First Posted

February 18, 2013

Record last verified: 2013-02

Locations

US(1)