Blood Coagulation Disorders, Complication of Dialysis, End Stage Renal Failure on Dialysis
Conditions
Keywords
hemodialysis, dialysis, renal dialysis, clotting, coagulation, blood lines
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 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.
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 was to prospectively examine the Streamline® airless tubing system in an inpatient setting and its association with clotting rates, and dialysis efficiency.
Interventions
None listed
Sponsors
NxStage Medical
Marie Hogan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clotting of Extracorporeal Dialysis Circuit | During the dialysis session, approximately 211 minutes | 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. |
Countries
United States
Participant flow
Recruitment details
338 patients were enrolled at the Mayo Clinic in Rochester, Minnesota from January 2014 to May 2015.
Participants by arm
| Arm | Count |
|---|---|
| General Care Cohort The group included adult hospitalized patients requiring hemodialysis at the inpatient dialysis unit. This was an observational study, with no interventions. | 156 |
| Critical Care Cohort The group included adult hospitalized patients requiring hemodialysis at the intensive care unit. This was an observational study, with no interventions. | 182 |
| Total | 338 |
Baseline characteristics
| Characteristic | General Care Cohort | Total | Critical Care Cohort |
|---|---|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 16 | 62.5 years STANDARD_DEVIATION 16.5 | 62 years STANDARD_DEVIATION 17 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 16 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 7 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 12 Participants | 3 Participants |
| Race (NIH/OMB) White | 133 Participants | 296 Participants | 163 Participants |
| Region of Enrollment United States | 156 participants | 338 participants | 182 participants |
| Sex: Female, Male Female | 60 Participants | 127 Participants | 67 Participants |
| Sex: Female, Male Male | 96 Participants | 211 Participants | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 31 / 156 | 40 / 182 |
| other Total, other adverse events | 0 / 156 | 0 / 182 |
| serious Total, serious adverse events | 0 / 156 | 0 / 182 |
Outcome results
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.
Time frame: During the dialysis session, approximately 211 minutes
Population: Units in the study referred to a dialysis session. A patient could have received dialysis more than once. Hence the number of patients (338) is less than the number of dialysis sessions (1200).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| General Care Cohort | Clotting of Extracorporeal Dialysis Circuit | 30 Clotting events |
| Critical Care Cohort | Clotting of Extracorporeal Dialysis Circuit | 33 Clotting events |
p-value: 0.79t-test, 2 sided