Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine if the overall fluid requirements for the first 24 hours after admission will be reduced with Hextend versus a standard of care crystalloid resuscitation fluid.
Following severe multi-system traumatic injury, the first 24 hours of standard resuscitation fluid will be either Hextend or crystalloid depending upon attending preference. No tests or interventions will be performed for research purposes.
Data will be collected prospectively from patient medical records and attending clinicians to monitor fluid requirements, hemodynamics and outcome.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | From hospital arrival up to an average of 3.5 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Adult Trauma Patients
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kenneth G Proctor, PhD | University of Miami | Principal Investigator |
| Carl I Schulman, MD, MSPH | University of Miami | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ryder Trauma Center | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17254930 | Background | Earle SA, de Moya MA, Zuccarelli JE, Norenberg MD, Proctor KG. Cerebrovascular resuscitation after polytrauma and fluid restriction. J Am Coll Surg. 2007 Feb;204(2):261-75. doi: 10.1016/j.jamcollsurg.2006.11.014. | |
| 15454801 | Background | Crookes BA, Cohn SM, Bonet H, Burton EA, Nelson J, Majetschak M, Varon AJ, Linden JM, Proctor KG. Building a better fluid for emergency resuscitation of traumatic brain injury. J Trauma. 2004 Sep;57(3):547-54. doi: 10.1097/01.ta.0000135162.85859.4c. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Hextend Plus Standard of Care | Hextend along with the routine Standard of Care Resuscitation Fluid |
| FG001 | Standard of Care | Routine Standard of Care Resuscitation Fluid |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Hextend Plus Standard of Care | Hextend along with the routine Standard of Care Resuscitation Fluid |
| BG001 | Standard of Care | Routine Standard of Care Resuscitation Fluid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mortality | Analysis was per protocol. | Posted | Number | participants | From hospital arrival up to an average of 3.5 weeks |
|
|
Adverse events were not collected for this observational study.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hextend Plus Standard of Care | Hextend along with the routine Standard of Care Resuscitation Fluid |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Proctor, PhD | University of Miami | 305-243-4694 | kproctor@med.miami.edu |
Not provided
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 15300202 | Background | King DR, Cohn SM, Proctor KG. Changes in intracranial pressure, coagulation, and neurologic outcome after resuscitation from experimental traumatic brain injury with hetastarch. Surgery. 2004 Aug;136(2):355-63. doi: 10.1016/j.surg.2004.05.011. |
| 12855887 | Background | Kelly ME, Miller PR, Greenhaw JJ, Fabian TC, Proctor KG. Novel resuscitation strategy for pulmonary contusion after severe chest trauma. J Trauma. 2003 Jul;55(1):94-105. doi: 10.1097/01.TA.0000029042.37577.A6. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 36 |
| 0 |
| 0 |
| EG001 | Standard of Care | Routine Standard of Care Resuscitation Fluid | 0 | 83 | 0 | 0 |
Not provided
Not provided