Trial record 3 of 469 for:    Open Studies | "Renal Dialysis"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Mayo Clinic
Sponsor:
Collaborator:
Medisystems Corporation
Information provided by (Responsible Party):
Marie Hogan, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02086682
First received: March 10, 2014
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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
End Stage Renal Failure on Dialysis
Complication of Dialysis
Blood Coagulation Disorders

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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:
  • Mean Clotting Score [ Time Frame: The patients will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1000
Study Start Date: February 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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=1000) is reached.

Exclusion Criteria:

  • Pregnant females
  • Children
  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: 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
Medisystems Corporation
Investigators
Principal Investigator: Marie C. Hogan, M.D., Ph.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Marie Hogan, Associate Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02086682     History of Changes
Other Study ID Numbers: 13-003161
Study First Received: March 10, 2014
Last Updated: March 11, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 22, 2014