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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02086682
Other study ID # 13-003161
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2014
Est. completion date August 2015

Study information

Verified date May 2019
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 was 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.


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 was to prospectively examine the Streamline® airless tubing system in an inpatient setting and its association with clotting rates, and dialysis efficiency.


Recruitment information / eligibility

Status Completed
Enrollment 338
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Pregnant females

- Children

Study Design


Locations

Country Name City State
United States Mayo Clinic Hospital, Saint Marys Campus Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Marie Hogan NxStage Medical

Country where clinical trial is conducted

United States, 

References & Publications (1)

Safadi S, Albright RC Jr, Dillon JJ, Williams AW, Alahdab F, Brown JK, Severson AL, Kremers WK, Ryan MA, Hogan MC. Prospective Study of Routine Heparin Avoidance Hemodialysis in a Tertiary Acute Care Inpatient Practice. Kidney Int Rep. 2017 Mar 16;2(4):69 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Clotting of Extracorporeal Dialysis Circuit Each dialysis session was prospectively observed for Clotting of Extracorporeal Dialysis Circuit. Events were defined as interruption of hemodialysis session, loss of the hemodialysis circuit, or inability to return blood to the patient upon rinse back. During the dialysis session, approximately 211 minutes
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