NCT01107314

Brief Summary

In this study we hope to delineate the typical vasoactive mediator response of trauma patients to shock. We plan to assess serum levels of vasopressin and also catecholamines, angiotensin, and cortisol during resuscitation of trauma patients to delineate high risk populations for vasopressin deficiency.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2010

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2011

Completed
Last Updated

January 17, 2018

Status Verified

March 1, 2012

Enrollment Period

1.2 years

First QC Date

April 19, 2010

Last Update Submit

January 12, 2018

Conditions

Body Response to Trauma

Study Arms (1)

trauma patient

SBP less than 90mmHg

Other: Phlebotomy

Interventions

PhlebotomyOTHER

Blood draws (total 48 cc blood)

trauma patient

Eligibility Criteria

Age18 Years - 98 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

observational study - trauma patients admitted to University Hospital

You may qualify if:

  • Patient is a male or female patient presumed to be at least 18 years of age;
  • Patient has a reported or actual systolic blood pressure \< 90 mmHg within 1 hour of arrival to the Emergency Room;
  • Patient has clinical evidence of acute traumatic injury;

You may not qualify if:

  • Patient is asystolic or requires CPR prior to arrival;
  • Patient was transferred from an outside facility
  • Patient known to be pregnant
  • Patient known to be prisoner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UTHSCSA

San Antonio, Texas, 78229-3900, United States

Location

MeSH Terms

Interventions

Phlebotomy

Intervention Hierarchy (Ancestors)

Blood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Stephen M Cohn, MD

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2010

First Posted

April 20, 2010

Study Start

February 1, 2010

Primary Completion

April 30, 2011

Study Completion

April 30, 2011

Last Updated

January 17, 2018

Record last verified: 2012-03

Locations

US(1)