Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

HeRO Graft Compared to Permanent Catheters for End Stage Renal Disease (ESRD) Patients Receiving Hemodialysis

This study has been completed.
Sponsor:
Collaborator:
CryoLife, Inc.
Information provided by (Responsible Party):
Hemosphere, Inc.
ClinicalTrials.gov Identifier:
NCT01343251
First received: April 20, 2011
Last updated: February 16, 2016
Last verified: February 2016
  Purpose
The main objective of this research study was to compare the following outcomes between patients with a Hemodialysis Reliable Outflow (HeRO) Graft and patients with a cuffed catheter for dialysis access over one year: quality of life and incidence of bacteremia, vascular interventions, hospitalizations, and death.

Condition
End Stage Renal Disease (ESRD)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Analysis of Hemodialysis Reliable Outflow (HeRO) Vascular Access Graft vs. Cuffed Catheter Access in Hemodialysis

Resource links provided by NLM:


Further study details as provided by Hemosphere, Inc.:

Primary Outcome Measures:
  • Mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Compare mortality rate between study arms


Secondary Outcome Measures:
  • Infection Rate (Percentage of Participants With at Least One Infection) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Compare incidence of infection between study arms

  • Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Compare the RAND Short Form (SF)-36 Health Survey, Total Test Scores at baseline, 3, 6, and 12 months between study arms. Total test scores range on a scale from 0-100, with the lower the score equating to more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. The total score is calculated using a methodology described by the RAND Corporation, which assigns a recoded value to each survey item. Recoded items are averaged amongst scales and the total score is an average of the eight sections. (http://www.rand.org/content/dam/rand/www/external/health/surveys_tools/mos/mos_core_36item_scoring.pdf).

  • Intervention Rate (Percentage of Participants Who Required at Least One Intervention While on Study) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Compare vascular intervention rates between study arms. The vascular interventions which were included were: Angioplasty, Thrombectomy, Arteriovenous (AV) Fistulogram/Diagnostic Angiogram, Banding, Access Removal, Access Exchange, Access Revision, Creation of New Access, and any combination of these interventions which were performed simultaneously.

  • Hospitalization Rate (Percentage of Participants Who Were Hospitalized at Least Once While on Study) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Compare incidence of hospitalization (for any reason) between study arms. Reasons for hospitalizations included: infection, cardiac problems, bleeding, vascular access thrombosis, fall (injury), hematuria, fluid overload, peripheral neuropathy, pulmonary embolism, edema, and shortness of breath.


Enrollment: 33
Study Start Date: January 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
HeRO Graft
patients who are evaluated and receive a HeRO Graft implant for hemodialysis
Control
control group of non-HeRO patients who are evaluated but do not receive a HeRO Graft for any reason

Detailed Description:

All eligible participants who provided informed consent were included in the study. Participants who refused HeRO Graft implantation, or did not have the HeRO Graft implanted for any other reason, were followed in the control group. Several patients did not receive the HeRO graft due to anatomical challenges and failure to complete both steps of the two-stage implant procedure. All consented participants who had an implanted HeRO Graft were followed in the study group. All participants were followed until the study end, withdrawal, loss to follow-up, or death. The analysis included only HeRO Graft patients and control patients who were not lost to follow-up; patients who were lost to follow-up, before data collection, were excluded from analysis.

After obtaining Institutional Review Board (IRB) approval, baseline demographic and clinical data was collected. Following surgery, implant procedure data was collected on study participants who received HeRO Grafts. HeRO Grafts were placed using a 2-step process with initial placement of the ePTFE portion, followed by completion of the graft by placement of the venous outflow component. Following enrollment, outcomes of interest were collected at follow-up visits scheduled weekly for 4 weeks, bi-weekly for 3 months, and monthly to 1 year, for a total of 18 follow-up visits. Study coordinators documented post-operative complications, incidence of thrombosis, hospitalizations, infection incidents, and deaths at each follow-up.

Quality of life data were also collected from all participants using the RAND Corporation's Short Form (36) (SF-36) Health Survey. This survey was completed at enrollment and again at 3 months, 6 months, and 12 months.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with ESRD requiring permanent cuffed catheters were targeted. Participants who had not exhausted peripheral venous access sites suitable for fistulas and grafts were excluded.
Criteria

Inclusion Criteria:

  • ESRD patients requiring hemodialysis
  • Age ≥ 18 years old
  • Able to give informed consent
  • Able to participate in quality of life survey
  • All patients who are not candidate for arteriovenous fistula (AVF) or arteriovenous graft (AVG)
  • Life expectancy 2 years or greater
  • Willing and able to participate with follow-up examinations

Exclusion Criteria:

  • Pregnant or breastfeeding females
  • Disorder that compromises the ability to give informed consent and/or comply with the study procedures
  • Any medical condition that in the opinion of the investigator may pose a safety risk to a subject in the study or which may interfere with the study participation
  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: NCT01343251

Locations
United States, Michigan
St. Clair Specialty Physicians
Detroit, Michigan, United States, 48236
Sponsors and Collaborators
Hemosphere, Inc.
CryoLife, Inc.
Investigators
Principal Investigator: Robert Provenzano, MD St. Clair Specialty Physicians
  More Information

Publications:
Ware JE, Kosinski M, Gandek. SF-36 Health Survey Manual & Interpretation Guide. Lincoln RI, Quality Metric Incorporated, 2000, pp. 10-14

Responsible Party: Hemosphere, Inc.
ClinicalTrials.gov Identifier: NCT01343251     History of Changes
Other Study ID Numbers: HeRO-1 
Study First Received: April 20, 2011
Results First Received: February 24, 2014
Last Updated: February 16, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Hemosphere, Inc.:
dialysis
HeRO graft
catheter
chronic renal failure
end stage renal disease
renal insufficiency

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 26, 2016