Use of Hextend in Trauma

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Kenneth Proctor, University of Miami

ClinicalTrials.gov Identifier:

NCT00983281

First received: September 23, 2009

Last updated: February 20, 2013

Last verified: February 2013

Results First Received: January 15, 2013

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Retrospective
Condition:	Trauma
Intervention:	Drug: Fluid resuscitation

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Hextend	Patients that received Hextend as part of their resuscitation fluid.
Standard of Care	Patients that received crystalloid but no Hextend as part of their resuscitation.

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
Hextend	Patients that received Hextend as part of their resuscitation fluid.
Standard of Care	Patients that received standard resuscitation but no Hextend as part of their resuscitation.
Total	Total of all reporting groups

Baseline Measures

	Hextend	Standard of Care	Total
Number of Participants [units: participants]	805	909	1714
Age [units: years] Mean ± Standard Deviation
Mean Age	39 ± 17	41 ± 18	40 ± 18
Gender [units: participants]
Female	152	190	342
Male	653	719	1372

Outcome Measures

1. Primary:

Mortality [ Time Frame: Overall inpatient mortality upon discharge from the hospital ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Kenneth Proctor, PhD
Organization: University of Miami
phone: 305-243-4694
e-mail: kproctor@med.miami.edu

No publications provided

Responsible Party:	Kenneth Proctor, University of Miami
ClinicalTrials.gov Identifier:	NCT00983281 History of Changes
Other Study ID Numbers:	20080598
Study First Received:	September 23, 2009
Results First Received:	January 15, 2013
Last Updated:	February 20, 2013
Health Authority:	United States: Institutional Review Board