Trial Outcomes & Findings for Use of Hextend in Trauma (NCT NCT00983281)
NCT ID: NCT00983281
Last Updated: 2017-06-14
Results Overview
Recruitment status
COMPLETED
Target enrollment
1714 participants
Primary outcome timeframe
Overall inpatient mortality upon discharge from the hospital with a mean length of stay of 8 days.
Results posted on
2017-06-14
Participant Flow
Participant milestones
| Measure |
Hextend
Patients that received Hextend as part of their resuscitation fluid.
|
Standard of Care
Patients that received standard of care but no Hextend as part of their resuscitation.
|
|---|---|---|
|
Overall Study
STARTED
|
805
|
909
|
|
Overall Study
COMPLETED
|
805
|
909
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Hextend in Trauma
Baseline characteristics by cohort
| Measure |
Hextend
n=805 Participants
Patients that received Hextend as part of their resuscitation fluid.
|
Standard of Care
n=909 Participants
Patients that received standard of care but no Hextend as part of their resuscitation.
|
Total
n=1714 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Mean Age
|
39 years
STANDARD_DEVIATION 17 • n=5 Participants
|
41 years
STANDARD_DEVIATION 18 • n=7 Participants
|
40 years
STANDARD_DEVIATION 18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
152 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
342 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
653 Participants
n=5 Participants
|
719 Participants
n=7 Participants
|
1372 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Overall inpatient mortality upon discharge from the hospital with a mean length of stay of 8 days.Outcome measures
| Measure |
Hextend
n=805 Participants
Patients that received Hextend as part of their resuscitation fluid.
|
Standard of Care
n=909 Participants
PAtients that did not receive Hextend as part of their resuscitation fluid.
|
|---|---|---|
|
Mortality
|
42 participants
|
81 participants
|
Adverse Events
Hextend
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