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Use of Hextend in Trauma

Use of Hextend in Trauma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00983281
Enrollment
1714
Registered
2009-09-24
Start date
2008-08-31
Completion date
2009-09-30
Last updated
2017-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma

Keywords

Combat casualty care, Hextend, Colloid

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.

Interventions

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

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Admission to the trauma center

Exclusion criteria

* Pregnant women, children, psychiatric patients and prisoners.

Design outcomes

Primary

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

Countries

United States

Participant flow

Participants by arm

ArmCount
Hextend
Patients that received Hextend as part of their resuscitation fluid.
805
Standard of Care
Patients that received standard of care but no Hextend as part of their resuscitation.
909
Total1,714

Baseline characteristics

CharacteristicHextendStandard of CareTotal
Age, Continuous
Mean Age
39 years
STANDARD_DEVIATION 17
41 years
STANDARD_DEVIATION 18
40 years
STANDARD_DEVIATION 18
Sex: Female, Male
Female
152 Participants190 Participants342 Participants
Sex: Female, Male
Male
653 Participants719 Participants1372 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Mortality

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

ArmMeasureValue (NUMBER)
HextendMortality42 participants
Standard of CareMortality81 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026