Hemodialysis Fistula Thrombosis, Kidney Failure
Conditions
Keywords
Access Blood Flow Monitoring, Clinical Trial Vascular Access, Fistula Failure, Hemodialysis, Vascular Access
Brief summary
The objective of the study is to determine whether clopidogrel reduces the early failure rate of native AV fistulae. This study was originally registered as NCT00067119 which included two protocols, this one and the GRAFT study)
Interventions
DRUGClopidogrel
DRUGPlacebo
Sponsors
The Cleveland Clinic
Boston University
Duke University
University of Iowa
MaineHealth
University of Texas Southwestern Medical Center
University of Alabama at Birmingham
Washington University School of Medicine
Baystate Medical Center
Vanderbilt University
CAMC Health System
Emory University
St. Louis University
Tyler Nephrology Associates
Vascular Surgery Associates LLC
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Fistula Study Protocol Inclusion Criteria: * Age 18-21 depending on state regulations * Life expectancy of at least six months * Chronic renal failure with anticipated start of hemodialysis within six months of enrollment, or current dialysis dependence * Planned creation of native upper extremity AV fistula * The patient is not on aspirin, or the patient is on aspirin but has not had a myocardial infarction or a cerebrovascular accident within the past 12 months. * The patient is expected to stay at a participating dialysis facility for at least 6 months. * The patient's physician(s) will allow the patient to participate. * Ability to give informed consent.
Exclusion criteria
* Women must not be pregnant, breastfeeding, or plan to be pregnant during the course of the study. * The presence of ongoing bleeding. * The presence of a known bleeding disorder (e.g., hemophilia or von Willebrand's disease). * Recent bleeding episode requiring transfusion within 12 weeks of entry. * The presence of acute ulcer disease. Acute ulcer disease is defined as a new diagnosis of peptic disease including esophagitis, gastritis, or ulcer or the initiation of treatment with proton pump inhibitors, H2 blockers or therapy for Helicobacter pylori within three months prior to obtaining consent. * A condition which prohibits discontinuation of anticoagulant drugs, aspirin, or nonsteroidal anti-inflammatory drugs during the six week study drug administration period. Use of heparin during dialysis is allowed. * Required use of oral or intravenous glucocorticoids at a dose greater than the equivalent of prednisone 15 mg per day during the six week study drug administration period. * Current unstable angina. * Required use of clopidogrel. * Known hypersensitivity to clopidogrel. * Medical considerations making anti-platelet therapy dangerous. * Current uncontrolled hypertension with systolic blood pressure in excess of 200 mm Hg or diastolic blood pressure in excess of 115 mm Hg at the time of enrollment. * Baseline platelet count less than 75,000/mm3. * Known advanced liver disease with decompensated cirrhosis, jaundice, ascites or bleeding varices. * Current problem with substance abuse. * Concurrent participation in another medical intervention trial. * Anticipated non-compliance with medical care based on physician judgment. * Patient refusal.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fistula thrombosis (patency failure) | 6 weeks | The fistula was classified as patent if a bruit was audible with a stethoscope throughout systole and diastole at least 8 cm proximal to the arteriovenous anastomosis. Fistula patency was assessed by trained study personnel. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Failure to attain suitability for dialysis (ability to use the fistula for dialysis with 2 needles and maintain a dialysis machine blood flow rate adequate for optimal dialysis (>=300 mL/min)) | 30 days | Fistula suitability was defined as the ability to use the fistula for dialysis with 2 needles and maintain a dialysis machine blood flow rate adequate for optimal dialysis (\>=300 mL/min) during 8 of 12 dialysis sessions occurring during a 30-day suitability ascertainment period. For participants receiving maintenance hemodialysis at the time of enrollment and for participants who started maintenance hemodialysis within 120 days after fistula creation, the suitability ascertainment period began between 120 and 150 days after fistula creation surgery. |
Countries
United States
Outcome results
None listed