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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hextend | Patients that received Hextend as part of their fluid resuscitation. |
| |
| Standard of Care | Patients that received standard fluid resuscitation but no Hextend. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hextend | Drug | IV fluid resuscitation to restore euvolemia after traumatic injury and surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Overall inpatient mortality upon discharge from the hospital with a mean length of stay of 8 days. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Trauma patients
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kenneth Proctor, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Hextend | Patients that received Hextend as part of their resuscitation fluid. |
| FG001 | Standard of Care | Patients that received standard of care but no Hextend as part of their resuscitation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Hextend | Patients that received Hextend as part of their resuscitation fluid. |
| BG001 | Standard of Care | Patients that received standard of care but no Hextend as part of their resuscitation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Posted | Number | participants | Overall inpatient mortality upon discharge from the hospital with a mean length of stay of 8 days. |
|
|
Not provided
Serious and/or other (non-serious) adverse events were not collected or assessed as part of this observational study.
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 | Patients that received Hextend as part of their 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
| ID | Term |
|---|---|
| D006895 | Hydroxyethyl Starch Derivatives |
| ID | Term |
|---|---|
| D013213 | Starch |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005936 | Glucans |
Not provided
Not provided
Not provided
Not provided
Not provided
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Standard of Care | Patients that received standard resuscitation but no Hextend as part of their resuscitation. | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D011134 |
| Polysaccharides |