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Trial record 11 of 420 for:    TRANEXAMIC ACID

Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients

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ClinicalTrials.gov Identifier: NCT02106962
Recruitment Status : Completed
First Posted : April 8, 2014
Results First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
Imprimis Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Mark Boiskin, California Institute of Renal Research

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Arteriovenous Fistula
Interventions Drug: Topical Tranexamic Acid 5% with bacitracin
Other: Topical Tranexamic Acid 25% with bacitracin
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Topical Tranexamic Acid 5% Topical Tranexamic Acid 25%
Hide Arm/Group Description Topical Tranexamic Acid 5% with bacitracin applied to the arterio-venous fistula site after completing dialysis, to measure clotting time. Topical Tranexamic Acid 25% with bacitracin applied to the arterio-venous fistula site after completing dialysis, to measure clotting time.
Period Title: Overall Study
Started 8 9
Completed 8 9
Not Completed 0 0
Arm/Group Title Topical Tranexamic Acid and Bacitracin 5% Tranexamic Acid and Bacitracin 25% Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 8 9 17
Hide Baseline Analysis Population Description
dialysis subjects using arteriovenous fistula for dialysis access
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 17 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  87.5%
8
  88.9%
15
  88.2%
>=65 years
1
  12.5%
1
  11.1%
2
  11.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 17 participants
Female
2
  25.0%
3
  33.3%
5
  29.4%
Male
6
  75.0%
6
  66.7%
12
  70.6%
1.Primary Outcome
Title Clotting TIme
Hide Description 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
Time Frame 13 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clotting Time Using Tranexamic Acid 5% Clotting Time Using Tranexamic Acid 25%
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 9 8
Mean (Full Range)
Unit of Measure: minutes
6
(3 to 15)
8
(3 to 15)
2.Secondary Outcome
Title Local Infection
Hide Description After using Tranexamic Acid and Bacitracin, local infection rate measured at the end of study
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
no local infection in any particioant
Arm/Group Title Topical Tranexamic Acid 5% Topical Tranexamic Acid 25 %
Hide Arm/Group Description:
Measure clotting time of Native arteriovenous fistula after applying topical Tranexamic Acid 5% compared with normal clotting time
Measure clotting time of Native arteriovenous fistula using Tranexamic acid 25% compared with normal clotting time
Overall Number of Participants Analyzed 8 9
Mean (Full Range)
Unit of Measure: participants
0
(0 to 0)
0
(0 to 0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Topical Tranexamic Acid 5% and Bacitracin Topical Tranexamic Acid 25% and Bacitracin
Hide Arm/Group Description Topical Tranexamic Acid 5% with bacitracin applied to the arterio-venous fistula site after completing dialysis, to measure clotting time. Topical Tranexamic Acid 25% with bacitracin was applied to the arterio-venous fistula site after completing dialysis, to measure clotting time at a subsequent dialysis session.
All-Cause Mortality
Topical Tranexamic Acid 5% and Bacitracin Topical Tranexamic Acid 25% and Bacitracin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/9 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Topical Tranexamic Acid 5% and Bacitracin Topical Tranexamic Acid 25% and Bacitracin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Topical Tranexamic Acid 5% and Bacitracin Topical Tranexamic Acid 25% and Bacitracin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/9 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mark M. Boiskin, M.D.
Organization: California Insitute of Renal Research, Inc.
Phone: 858-637-4600
EMail: mboiskin@bnmg.org
Layout table for additonal information
Responsible Party: Mark Boiskin, California Institute of Renal Research
ClinicalTrials.gov Identifier: NCT02106962     History of Changes
Other Study ID Numbers: 001-Boiskin
First Submitted: April 4, 2014
First Posted: April 8, 2014
Results First Submitted: July 28, 2016
Results First Posted: September 25, 2017
Last Update Posted: September 25, 2017