Trial Outcomes & Findings for Optimal Fluid Resuscitation for Trauma Patients (NCT NCT00527098)
NCT ID: NCT00527098
Last Updated: 2013-02-22
Results Overview
Recruitment status
COMPLETED
Target enrollment
119 participants
Primary outcome timeframe
From hospital arrival up to an average of 3.5 weeks
Results posted on
2013-02-22
Participant Flow
Participant milestones
| Measure |
Hextend Plus Standard of Care
Hextend along with the routine Standard of Care Resuscitation Fluid
|
Standard of Care
Routine Standard of Care Resuscitation Fluid
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
83
|
|
Overall Study
COMPLETED
|
36
|
83
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimal Fluid Resuscitation for Trauma Patients
Baseline characteristics by cohort
| Measure |
Hextend Plus Standard of Care
n=36 Participants
Hextend along with the routine Standard of Care Resuscitation Fluid
|
Standard of Care
n=83 Participants
Routine Standard of Care Resuscitation Fluid
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
39 years
STANDARD_DEVIATION 17 • n=5 Participants
|
39 years
STANDARD_DEVIATION 17 • n=7 Participants
|
39 years
STANDARD_DEVIATION 17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
83 participants
n=7 Participants
|
119 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From hospital arrival up to an average of 3.5 weeksPopulation: Analysis was per protocol.
Outcome measures
| Measure |
Observational
n=119 Participants
This is an observational trial.
|
|---|---|
|
Mortality
|
0 participants
|
Adverse Events
Hextend Plus Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place