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CompletedNCT00983281Updated Jun 14, 2017Results posted

Use of Hextend in Trauma

An observational study in Trauma, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-14.

Sponsored by University of Miami · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,714
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Trauma

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Keywords

  • Combat casualty care
  • Hextend
  • Colloid
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 1,714 is above the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Trauma patients

Inclusion criteria

  • Admission to the trauma center

Exclusion criteria

Exclusion Criteria:

  • Pregnant women, children, psychiatric patients and prisoners.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,714 participants (actual)

Groups and cohorts

  • 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

  • DrugHextend

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

06

What researchers measure

Primary outcomes

  1. Mortality

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

07

Results

Posted Feb 18, 2013

Participant flow

Participant flow — Overall Study
MilestoneHextendStandard of Care
Started805909
Completed805909
Not completed00

Outcome measures

PrimaryMortality
Time frame:
Overall inpatient mortality upon discharge from the hospital with a mean length of stay of 8 days.
Reported as:
Number · participants
Mortality
participantsHextendStandard of Care
Mortality4281

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Hextend———
Standard of Care———

Baseline characteristics

Age, Continuous
Age, Continuous(years)HextendStandard of CareTotal
Mean Age39 ± 1741 ± 1840 ± 18
Sex: Female, Male
Sex: Female, Male(Participants)HextendStandard of CareTotal
Female152190342
Male6537191372
08

Study locations

1 site
  • University of Miami
    Miami, Florida 33136, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00983281
Lead sponsor
University of Miami
Responsible party
Kenneth Proctor (Professor, University of Miami) — Principal investigator
First posted
Sep 24, 2009
Start date
Aug 2008
Primary completion
Sep 2009
Completion
Sep 2009
Results posted
Feb 18, 2013
Last update
Jun 14, 2017

Study contacts

Kenneth Proctor, PhD
principal investigator · University of Miami

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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