Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients

NCT02106962 | Completed Phase 4 Results

• 1 other identifier: 001-Boiskin
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief Summary

This study will investigate how the use of Tranexamic acid and Bacitracin applied to the bleeding site after the hemodialysis fistula needle is removed will affect Time to Clot and Infection Rate

Conditions

Arteriovenous Fistula

Keywords

hemodialysis; fistula; clotting; tranexamic acid; bacitracin

Outcome Measures

Primary Outcomes (1)

• Clotting TIme

  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

  13 minutes

Secondary Outcomes (1)

• Local Infection

  2 months

Study Arms (2)

Clotting time Using Tranexamic Acid 5%

EXPERIMENTAL

Measure Native AV Fistula clotting time after dialysis using 5% Tranexamic Acid compared to normal Clotting time of Native AV Fistula after dialysis

Drug: Topical Tranexamic Acid 5% with bacitracin

Clotting Time Using Tranexamic Acid 25%

EXPERIMENTAL

Measure Native AV Fistula clotting time after dialysis using 25% Tranxemic Acid compared to normal clotting time of native AV Fistula after dialysis

Other: Topical Tranexamic Acid 25% with bacitracin

Interventions

Topical Tranexamic Acid 5% with bacitracin DRUG

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.

Also known as: Cyklokapron

Clotting time Using Tranexamic Acid 5%

Topical Tranexamic Acid 25% with bacitracin OTHER

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.

Also known as: Cyklokapron

Clotting Time Using Tranexamic Acid 25%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dialysis patients with fistulas (native arterio-venous)

You may not qualify if:

• Previous sensitivity to or adverse reaction to Tranexamic acid or Bacitracin.
• Active infection.
• Stenosis of fistula.

Sponsors & Collaborators

• California Institute of Renal Research: lead
• Imprimis Pharmaceuticals, Inc.: collaborator

Study Sites (3)

Fresenius Medical Care - Kearny Mesa

San Diego, California, 92111, United States

Location

California Insitute of Renal Research

San Diego, California, 92123, United States

Location

Fresenious Medical Care - Rancho

San Diego, California, 92127, United States

Location

MeSH Terms

Conditions

Arteriovenous Fistula; Fistula; Thrombosis

Interventions

Tranexamic Acid; Bacitracin

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Mark M. Boiskin, M.D.
• Organization: California Insitute of Renal Research, Inc.

mboiskin@bnmg.org

858-637-4600

Study Officials

• Mark Boiskin, MD

  California Institute of Renal Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 8, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 25, 2017
• Results First Posted: September 25, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)