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

NCT02086682 | Completed Results

• 1 other identifier: 13-003161
• Study Type: observational
• Target: 338
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

hemodialysis; dialysis; renal dialysis; clotting; coagulation; blood lines

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The group included adult hospitalized patients requiring hemodialysis at the inpatient dialysis unit or the ICU during the recruitment period.

You may qualify if:

• 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.

You may not qualify if:

• Pregnant females
• Children

Sponsors & Collaborators

• Marie Hogan: lead
• NxStage Medical: collaborator

Study Sites (1)

Mayo Clinic Hospital, Saint Marys Campus

Rochester, Minnesota, 55902, United States

Location

Related 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):695-704. doi: 10.1016/j.ekir.2017.03.003. eCollection 2017 Jul.

  PMID: 29142987 RESULT

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Blood Coagulation Disorders; Thrombosis

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Marie Hogan
• Organization: Mayo Clinic

Hogan.Marie@mayo.edu

507-266 -1963

Study Officials

• Marie C. Hogan, M.D., Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: March 13, 2014
• Study Start: January 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: July 15, 2019
• Results First Posted: July 15, 2019

Record last verified: 2019-05

Locations

US (1)