Trial Outcomes & Findings for Safety and Efficacy of Oral TXA in Reducing Blood Loss and Transfusion in Hip Fractures (NCT NCT02908516)
NCT ID: NCT02908516
Last Updated: 2019-07-29
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
6 participants
Primary outcome timeframe
Postoperative day 3
Results posted on
2019-07-29
Participant Flow
Participant milestones
| Measure |
Tranexamic Acid
Study subjects randomized to receive the TXA group will receive 3 oral capsules of 650 mg each of TXA for a total of 1.95 g. One dose will be given upon diagnosis of a hip fracture in the emergency department (ED) and a second dose will be given two hours prior to surgical incision.
Tranexamic Acid: 2 doses of 1.95 g TXA orally, once in the ED and another dose pre-operatively.
|
Placebo
Study subjects randomized to the placebo group will receive an equivalent dose of cellulose in 3 oral capsules. One dose will be given upon diagnosis of a hip fracture in the ED and a second dose will be given two hours prior to surgical incision.
Placebo: 2 doses of 1.95 g cellulose orally, once in the ED and another dose pre-operatively.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Tranexamic Acid
Study subjects randomized to receive the TXA group will receive 3 oral capsules of 650 mg each of TXA for a total of 1.95 g. One dose will be given upon diagnosis of a hip fracture in the emergency department (ED) and a second dose will be given two hours prior to surgical incision.
Tranexamic Acid: 2 doses of 1.95 g TXA orally, once in the ED and another dose pre-operatively.
|
Placebo
Study subjects randomized to the placebo group will receive an equivalent dose of cellulose in 3 oral capsules. One dose will be given upon diagnosis of a hip fracture in the ED and a second dose will be given two hours prior to surgical incision.
Placebo: 2 doses of 1.95 g cellulose orally, once in the ED and another dose pre-operatively.
|
|---|---|---|
|
Overall Study
Study Terminated
|
3
|
3
|
Baseline Characteristics
Safety and Efficacy of Oral TXA in Reducing Blood Loss and Transfusion in Hip Fractures
Baseline characteristics by cohort
| Measure |
Tranexamic Acid
n=3 Participants
Study subjects randomized to receive the TXA group will receive 3 oral capsules of 650 mg each of TXA for a total of 1.95 g. One dose will be given upon diagnosis of a hip fracture in the emergency department (ED) and a second dose will be given two hours prior to surgical incision.
Tranexamic Acid: 2 doses of 1.95 g TXA orally, once in the ED and another dose pre-operatively.
|
Placebo
n=3 Participants
Study subjects randomized to the placebo group will receive an equivalent dose of cellulose in 3 oral capsules. One dose will be given upon diagnosis of a hip fracture in the ED and a second dose will be given two hours prior to surgical incision.
Placebo: 2 doses of 1.95 g cellulose orally, once in the ED and another dose pre-operatively.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
3 participants
n=4 Participants
|
6 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Postoperative day 3Population: Data were not collected post surgery due to study termination.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From presentation until postoperative day 3Population: Data were not collected post surgery due to study termination.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Postoperative day 3Population: Data were not collected post surgery due to study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During hospitalization, likely less than 1 weekPopulation: Data were not collected post surgery due to study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeksPopulation: Data were not collected post surgery due to study termination.
Data were not collected post surgery due to study termination.
Outcome measures
Outcome data not reported
Adverse Events
Tranexamic Acid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Dr. Michael P. Leslie
Yale School of Medicine, Department of Orthopaedics and Rehabilitation
Phone: (203) 737-6358
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place