A Prospective Study of Airless Tubing in an Inpatient Acute Hemodialysis Unit in Hospitalized Patients
|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
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|
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 Type :||Observational|
|Estimated Enrollment :||1200 participants|
|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|
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086682
|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|
|United States, Minnesota|
|Mayo Clinic Hospital, Saint Marys Campus||Recruiting|
|Rochester, Minnesota, United States, 55902|
|Principal Investigator: Sami Safadi, M.D.|
|Principal Investigator:||Marie C. Hogan, M.D., Ph.D.||Mayo Clinic|