HeRO Vascular Access Device Bacteremia Study

This study has been completed.
Sponsor:
Collaborators:
Integra Clinical Trial Solutions - statistical analysis
Ross, John, M.D.
Information provided by:
Hemosphere, Inc.
ClinicalTrials.gov Identifier:
NCT00889564
First received: April 27, 2009
Last updated: April 28, 2009
Last verified: April 2009
  Purpose

The purpose of this study is to compare the safety and effectiveness of the HeRO Vascular Access Device in access challenged (e.g., catheter-dependent) hemodialysis patients. It is hypothesized the bacteremia rate associated with the HeRO device will be lower than a historical literature control of tunneled dialysis catheters.


Condition Intervention
Hemodialysis
Device: HeRO Vascular Access Device

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HeRO Vascular Access Device Bacteremia Study

Resource links provided by NLM:


Further study details as provided by Hemosphere, Inc.:

Primary Outcome Measures:
  • HeRO superiority in device and implant procedure-related bacteremia compared to historical tunneled dialysis catheter literature control [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of serious device or implant procedure-related serious adverse events and loss of secondary patency [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 38
Study Start Date: March 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: HeRO Vascular Access Device
    Long-term subcutaneous vascular access device for hemodialysis
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 21 years of age or older.
  2. Male or non-pregnant female.
  3. Life expectancy less than 1 year.
  4. ESRD on hemodialysis with poor remaining venous access sites for creation of an AV fistula or placement of a graft in the upper extremities.
  5. Implant side central venous system that surgeon believes can be accessed with interventional devices and can accommodate the 19 Fr GVAS device.
  6. Potential GVAS target brachial artery ≥ 3 mm in diameter determined by any suitable measure.
  7. Ability to understand and provide written informed consent.
  8. Willing and able to cooperate with follow-up examinations.

Exclusion Criteria:

  1. Documented history of drug abuse within six months prior to enrollment.
  2. "Planned" concomitant surgical procedure or previous major surgery within 30 days, excluding vascular access related procedures.
  3. Currently being treated with another investigational device or drug.
  4. Known bleeding diathesis or hypercoaguable state.
  5. Peripheral white blood cell count 1.5 K/mm3 or platelet count 50 K/mm3.
  6. Degenerative connective tissue disease, e.g., Marfan's and Ehlers Danlos Syndrome. Subjects with Lupus Erythematosus may be enrolled if receiving no immunosuppressants or low dose prednisone only (< 10 mg/day orally).
  7. Subjects with known or suspected concomitant active bacterial, fungal, viral, or parasitic infection. Subjects with Hepatitis B and/or Hepatitis C may be enrolled. Subjects who are HIV + with CD4 count of < 200 are excluded. Subjects with bacteremia within the past six (6) weeks must have negative blood cultures one week after completing appropriate antibiotic therapy prior to enrollment.
  8. Severe underlying co-morbidity or immediate life-threatening condition.
  9. Subjects with any condition which, in the opinion of the investigator, could preclude evaluation of response or completion of follow-up or affect subject safety.
  10. Subjects with significant arterial occlusive disease which would preclude safe placement of an upper extremity hemodialysis access.
  11. Subjects with history or findings on physical examination suggesting significant arterial insufficiency that could affect patient safety and/or device performance in the extremity planned for use with GVAS (i.e., steal syndrome, hand ischemia, peripheral arterial vascular disease, etc.).
  12. Subjects with scheduled kidney transplant within the next 12 months.
  13. Subjects with history of superior vena cava syndrome are excluded unless it was induced by previous access (these subjects can be enrolled).
  14. Subjects with history of decreased cardiac output with ejection fraction < 20% and/or NYHA class III or IV. NYHA definitions: Class III - Subjects with marked limitation of activity; they are comfortable only at rest; Class IV - Subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest.
  15. Subjects with history of uncorrected hypotension with systolic blood pressures routinely < 100 mg Hg.
  16. Subjects who currently have a pacemaker or ICD in their central venous system on the same side where the GVAS device would be implanted.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889564

Locations
United States, Florida
University of Miami / Cedars Medical Center
Miami, Florida, United States, 33125
United States, Georgia
St. Joseph's Hospital
Atlanta, Georgia, United States, 30342
United States, Illinois
Southern Illinois University
Springfield, Illinois, United States, 62702
United States, Minnesota
North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422
United States, South Carolina
Bamberg County Hospital
Bamberg, South Carolina, United States, 29003
United States, Texas
Baptist Medical Center
San Antonio, Texas, United States, 78205
United States, Virginia
Sentara Heart Hospital
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Hemosphere, Inc.
Integra Clinical Trial Solutions - statistical analysis
Ross, John, M.D.
Investigators
Principal Investigator: John Ross, MD Bamberg County Hospital
  More Information

No publications provided

Responsible Party: Andrea Fenton Abbs, Hemosphere, Inc.
ClinicalTrials.gov Identifier: NCT00889564     History of Changes
Other Study ID Numbers: 11-0050
Study First Received: April 27, 2009
Last Updated: April 28, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Hemosphere, Inc.:
Vascular access for hemodialysis
Catheter dependent patients
Access challenged patients
Bacteremia
HeRO Vascular Access Device

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014