Heparin Versus Normal Saline in Peripherally Inserted Central Catheter Lines

Comparative Effectiveness of Heparin Versus Normal Saline in Maintaining Patency of Peripherally Inserted Central Catheter Lines in Oncology Inpatients

The study team will be performing a study comparing the use of Heparin Flushes vs. Normal Saline Flushes in making sure central lines stay open. The participants will be placed in a group to receive the University of Texas Southwestern Medical Center (UTSW) Standard of Care (control group) for maintaining central lines, or a group to receive Normal Saline Flushes only (experimental group) to keep their central line open. The participants electronic medical record will be reviewed by study team members for the inclusion/exclusion criteria, the participants central line will be assessed by an 11 Blue BMT nurse every 12 hours, and they may be asked questions regarding their medical history during their stay on 11 Blue BMT. If a participant is discharged or transferred off of the 11 Blue BMT unit, they will no longer be included in the study and their central line maintenance will return to the UTSW Standard of Care. Participants in this study may be at risk for central line occlusion (a blood clot) which could require intervention to regain the free flow of fluids and use of the central line. The study team predicts there will be no increase in the rate of line occlusion when using Normal Saline Flushes only to maintain the free flow of fluids through participants central line. The study team also hopes the results of this study will help to improve patient outcomes by decreasing risk of infection, heparin associated complications, and costs.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Drug: Heparin Group; Drug: Normal Saline Group

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Clements University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Oncology patients
• Admitted to 11Blue Bone Marrow Transplant Unit at Clements University Hospital University of Texas Southwestern Medical Center
• Ages 18-80 years
• Pre-existing or newly placed PICC line
• PICC line with good blood return (defined as: "brisk blood return of 3cc")
• Flushes without difficulty

Exclusion Criteria:

• Patient less than 18 years of age or greater than 80 years of age
• Refused or unable to give consent to the study
• Patient admitted to the 11Blue BMT unit with any line other than a PICC line, or multiple lines
• Patient admitted to 11Blue BMT for active transplant
• Patient with a coagulopathy diagnosis
• Patient on therapeutic dose of anticoagulants for documented Deep Vein Thrombosis or Pulmonary Embolism
• Patient on inpatient hospice/comfort care
• Patient transferred off 11B BMT unit onto another floor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Heparin Group; Participants will receive the UTSW standard of of care for PICC line maintenance. All lumens of PICC line will be flushed w/ Heparin Flush every 8 hours. PICC line will be flushed with 10cc Normal Saline followed by 3cc Heparin Flush after administration of medication, blood products, or blood draws.	Drug: Heparin Group; All lumens of PICC line will be flushed w/ Heparin Flush every 8 hours. PICC line will be flushed with 10cc Normal Saline followed by 3cc Heparin Flush after administration of medication, blood products, or blood draws.; Other Names: Heparin Flush
Experimental: Normal Saline Group; Participants will receive only Normal Saline for PICC line maintenance. All lumens of PICC line will be flushed every 24 hours with 10cc Normal Saline. PICC line will be flushed with 10cc Normal Saline after administration of medication, blood products, or blood draws.	Drug: Normal Saline Group; A 10cc NS flush will be administered intravenously through the peripherally inserted central line catheter after administration of medication, blood products, and blood draws. In addition the peripherally inserted central line catheter will be flushed intravenously with 10cc Normal Saline every 24 hours.; Other Names: NS Flush, Normal Saline Flush, 0.9% Normal Saline Flush

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patency	To determine whether or not flushing central lines with normal saline only will maintain free flow through these central lines.	Up to Day 7 of enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection Rate	To determine whether or not removing Heparin Flushes from PICC line maintenance decreases the risk for central line associated infections	From Day 1 and up to Day 7 of enrollment

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Meredith C Allen, BSN, University of Texas Southwestern Medical Center; Study Chair: Teresa Phan, University of Texas Southwestern Medical Center; Study Director: Linda Denke, University of Texas Southwestern Medical Center; Study Chair: Kavitha Nair, University of Texas Southwestern Medical Center; Study Chair: Miriam Gonzales, University of Texas Southwestern Medical Center; Study Chair: Ramona Warkola, University of Texas Southwestern Medical Center; Study Chair: Jancy Wilson, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2020
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Peripherally Inserted Central Lines; Heparin Flush
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: STU-2018-0340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes