Trial Outcomes & Findings for Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients (NCT NCT02106962)
NCT ID: NCT02106962
Last Updated: 2017-09-25
Results Overview
After completing dialysis, the clotting time of the arteriovenous fistula of each participant was measured, using either Tranexamic Acid 5% or Tranexamic Acid 25% and compared to the regular clotting time of the AV Fistula without using the Tranexamic Acid
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
17 participants
Primary outcome timeframe
13 minutes
Results posted on
2017-09-25
Participant Flow
Participant milestones
| Measure |
Topical Tranexamic Acid 5%
Topical Tranexamic Acid 5% with bacitracin applied to the arterio-venous fistula site after completing dialysis, to measure clotting time.
|
Topical Tranexamic Acid 25%
Topical Tranexamic Acid 25% with bacitracin applied to the arterio-venous fistula site after completing dialysis, to measure clotting time.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients
Baseline characteristics by cohort
| Measure |
Topical Tranexamic Acid and Bacitracin 5%
n=8 Participants
Topical Tranexamic Acid 5% with bacitracin applied to the arterio-venous fistula site after completing dialysis, to measure clotting time in the same participants that did not receive treatment at a subsequent dialysis session
|
Tranexamic Acid and Bacitracin 25%
n=9 Participants
Topical Tranexamic Acid 25% with bacitracin applied to the arterio-venous fistula site after completing dialysis, to measure clotting time in the same participants that received treatment but at a subsequent dialysis session.
|
Total
n=17 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
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 13 minutesAfter completing dialysis, the clotting time of the arteriovenous fistula of each participant was measured, using either Tranexamic Acid 5% or Tranexamic Acid 25% and compared to the regular clotting time of the AV Fistula without using the Tranexamic Acid
Outcome measures
| Measure |
Clotting Time Using Tranexamic Acid 5%
n=9 Participants
Measure Native AV Fistula clotting time after dialysis using 5% Tranexamic Acid compared to normal Clotting time of Native AV Fistula after dialysis
Topical Tranexamic Acid 5% with bacitracin: Selected participants received a fixed amount of tranexamic acid 5 %and bacitracin applied with compression up to 3 times (13 minutes total) per hemodialysis fistula needle site.
|
Clotting Time Using Tranexamic Acid 25%
n=8 Participants
Measure Native AV Fistula clotting time after dialysis using 25% Tranxemic Acid compared to normal clotting time of native AV Fistula after dialysis
Topical Tranexamic Acid 25% with bacitracin: Selected participants received a fixed amount of tranexamic acid 25%and bacitracin applied with compression up to 3 times (13 minutes total) per hemodialysis fistula needle site.
|
|---|---|---|
|
Clotting TIme
|
6 minutes
Interval 3.0 to 15.0
|
8 minutes
Interval 3.0 to 15.0
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: no local infection in any particioant
After using Tranexamic Acid and Bacitracin, local infection rate measured at the end of study
Outcome measures
| Measure |
Clotting Time Using Tranexamic Acid 5%
n=8 Participants
Measure Native AV Fistula clotting time after dialysis using 5% Tranexamic Acid compared to normal Clotting time of Native AV Fistula after dialysis
Topical Tranexamic Acid 5% with bacitracin: Selected participants received a fixed amount of tranexamic acid 5 %and bacitracin applied with compression up to 3 times (13 minutes total) per hemodialysis fistula needle site.
|
Clotting Time Using Tranexamic Acid 25%
n=9 Participants
Measure Native AV Fistula clotting time after dialysis using 25% Tranxemic Acid compared to normal clotting time of native AV Fistula after dialysis
Topical Tranexamic Acid 25% with bacitracin: Selected participants received a fixed amount of tranexamic acid 25%and bacitracin applied with compression up to 3 times (13 minutes total) per hemodialysis fistula needle site.
|
|---|---|---|
|
Local Infection
|
0 participants
Interval 0.0 to 0.0
|
0 participants
Interval 0.0 to 0.0
|
Adverse Events
Topical Tranexamic Acid 5% and Bacitracin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Topical Tranexamic Acid 25% and Bacitracin
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
Mark M. Boiskin, M.D.
California Insitute of Renal Research, Inc.
Phone: 858-637-4600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place