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A Prospective Study of Airless Tubing in an Inpatient Acute Hemodialysis Unit in Hospitalized Patients

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ClinicalTrials.gov Identifier: NCT02086682
Recruitment Status : Unknown
Verified April 2015 by Marie Hogan, Mayo Clinic.
Recruitment status was:  Recruiting
First Posted : March 13, 2014
Last Update Posted : April 7, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The introduction of unfractionated heparin (UFH), which prevents clotting of the extracorporal circuit, was one of the key advances that led to the rapid development and expansion of hemodialysis services. However, anticoagulation during hemodialysis of the patient at high risk for bleeding remains a frequently encountered problem in both inpatient and outpatient dialysis practice.

Streamline bloodlines are designed to eliminate blood-air contact. This is thought to help reduce heparin use and decrease clotting rates. The goal of this study is to prospectively examine impact of the Streamline airless blood tubing set, in an inpatient setting, on dialysis circuit clotting rates, anticoagulation use, and dialysis efficiency.


Condition or disease
End Stage Renal Failure on Dialysis Complication of Dialysis Blood Coagulation Disorders

Detailed Description:

The introduction of unfractionated heparin (UFH), which prevents clotting of the extracorporeal circuit, was one of the key advances that led to the rapid development and expansion of hemodialysis use, and remains the mainstay in hemodialysis practice today.

However, anticoagulation during hemodialysis of the patient at high risk for bleeding remains a frequently encountered problem in the nephrology practice. The need for anticoagulation to prevent clotting of the extracorporeal blood circuit and the need to prevent anticoagulation related bleeding complications in the patient has led to the development of numerous strategies; the safest from a bleeding standpoint being anticoagulant-free hemodialysis.

Streamline® bloodlines (Medisystems® Corporation, Lawrence, MA) are designed to eliminate blood-air contact. A pressure pod measures arterial and venous pressures without any blood-air contact. The venous chamber is run without an air gap. It is also designed so that blood flows in a circular vortex manner. This airless system is thought to provide several benefits: improved dialysis efficiency and blood flow rates, reduced heparin use and clotting rates.

The goal of this study is to prospectively examine the Streamline® airless tubing system in an inpatient setting and its association with clotting rates, and dialysis efficiency.


Study Design

Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Airless Tubing in an Inpatient Acute Hemodialysis Unit in Hospitalized Patients in a Large Medical Center
Study Start Date : February 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Hospitalized patients
The group includes adult hospitalized patients requiring hemodialysis at the inpatient dialysis unit or the ICU. The study is observational, and no intervention is administered.


Outcome Measures

Primary Outcome Measures :
  1. Incidence of clinically significant clotting events during hemodialysis [ Time Frame: The patients will be followed for the duration of hospital stay, an expected average of 2 weeks. ]
    A clinically significant clotting event can happen at anytime during the dialysis session. It is defined as clotting event that results in frequent alarms, interruption of dialysis, requirement of a new dialysis setup, or inability to return blood to the patient.


Secondary Outcome Measures :
  1. Mean Clotting Score [ Time Frame: The patients will be followed for the duration of hospital stay, an expected average of 2 weeks ]
    A clotting score will be assigned based on the clotting assessment scale that is provided by the manufacturer, Medisystems. The dialysis nurse will perform the assessment at the end of dialysis after the rinse back. The scale incorporates five variables that are scored independently. Adding the above scores will result in the final score. 0 = no clotting in the equipment, 14 = severe clotting in the equipment.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The group includes adult hospitalized patients requiring hemodialysis at the inpatient dialysis unit or the ICU during the recruitment period.
Criteria

Inclusion Criteria:

  • All adult non-pregnant patients requiring inpatient hemodialysis at our center during the recruitment period until the target sample (n=1200) is reached.

Exclusion Criteria:

  • Pregnant females
  • Children
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086682


Contacts
Contact: Marie C. Hogan, M.D., Ph.D. 507-266-1963 Hogan.Marie@mayo.edu
Contact: Sami Safadi, M.D. 507-255-1088 Safadi.Sami@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Hospital, Saint Marys Campus Recruiting
Rochester, Minnesota, United States, 55902
Principal Investigator: Sami Safadi, M.D.         
Sponsors and Collaborators
Marie Hogan
NxStage Medical
Investigators
Principal Investigator: Marie C. Hogan, M.D., Ph.D. Mayo Clinic
More Information

Responsible Party: Marie Hogan, Associate Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02086682     History of Changes
Other Study ID Numbers: 13-003161
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015

Keywords provided by Marie Hogan, Mayo Clinic:
hemodialysis
dialysis
renal dialysis
clotting
coagulation
blood lines

Additional relevant MeSH terms:
Renal Insufficiency
Blood Coagulation Disorders
Hemostatic Disorders
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Renal Insufficiency, Chronic