Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| NxStage Medical | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General Care Cohort | The group included adult hospitalized patients requiring hemodialysis at the inpatient dialysis unit. This was an observational study, with no interventions. | ||
| Critical Care Cohort | The group included adult hospitalized patients requiring hemodialysis at the intensive care unit. This was an observational study, with no interventions. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The group included adult hospitalized patients requiring hemodialysis at the inpatient dialysis unit or the ICU during the recruitment period.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marie C. Hogan, M.D., Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Hospital, Saint Marys Campus | Rochester | Minnesota | 55902 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29142987 | Result | 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):695-704. doi: 10.1016/j.ekir.2017.03.003. eCollection 2017 Jul. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
338 patients were enrolled at the Mayo Clinic in Rochester, Minnesota from January 2014 to May 2015.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | General Care Cohort | The group included adult hospitalized patients requiring hemodialysis at the inpatient dialysis unit. This was an observational study, with no interventions. |
| FG001 | Critical Care Cohort | The group included adult hospitalized patients requiring hemodialysis at the intensive care unit. This was an observational study, with no interventions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | General Care Cohort | The group included adult hospitalized patients requiring hemodialysis at the inpatient dialysis unit. This was an observational study, with no interventions. |
| BG001 | Critical Care Cohort |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Number | Clotting events | During the dialysis session, approximately 211 minutes | Dialysis Sessions | Dialysis Sessions |
|
30 days after hospital admission
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | General Care Cohort | The group included adult hospitalized patients requiring hemodialysis at the inpatient dialysis unit. This was an observational study, with no interventions. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marie Hogan | Mayo Clinic | 507-266 -1963 | Hogan.Marie@mayo.edu |
Not provided
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
The group included adult hospitalized patients requiring hemodialysis at the intensive care unit. This was an observational study, with no interventions.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Critical Care Cohort |
The group included adult hospitalized patients requiring hemodialysis at the intensive care unit. This was an observational study, with no interventions. |
|
|
|
| 31 |
| 156 |
| 0 |
| 156 |
| 0 |
| 156 |
| EG001 | Critical Care Cohort | The group included adult hospitalized patients requiring hemodialysis at the intensive care unit. This was an observational study, with no interventions. | 40 | 182 | 0 | 182 | 0 | 182 |
Not provided
Not provided
| D002318 | Cardiovascular Diseases |