Heparin Versus Normal Saline in Peripherally Inserted Central Catheter Lines

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05029596
Collaborator
(none)
175
1
2
29.6
5.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Normal Saline Group
  • Drug: Heparin Group
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
175 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Comparative Effectiveness of Heparin Versus Normal Saline in Maintaining Patency of Peripherally Inserted Central Catheter Lines in Oncology Inpatients
Actual Study Start Date :
Feb 12, 2020
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Patency [Up to Day 7 of enrollment]

      To determine whether or not flushing central lines with normal saline only will maintain free flow through these central lines.

    Secondary Outcome Measures

    1. Infection Rate [From Day 1 and up to Day 7 of enrollment]

      To determine whether or not removing Heparin Flushes from PICC line maintenance decreases the risk for central line associated infections

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clements University Hospital Dallas Texas United States 75390

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Meredith Allen, Registered Nurse, University of Texas Southwestern Medical Center
    ClinicalTrials.gov Identifier:
    NCT05029596
    Other Study ID Numbers:
    • STU-2018-0340
    First Posted:
    Aug 31, 2021
    Last Update Posted:
    Aug 31, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Meredith Allen, Registered Nurse, University of Texas Southwestern Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 31, 2021