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Heparin Versus Normal Saline in Peripherally Inserted Central Catheter Lines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05029596
Recruitment Status : Recruiting
First Posted : August 31, 2021
Last Update Posted : August 30, 2022
Sponsor:
Information provided by (Responsible Party):
Meredith Allen, University of Texas Southwestern Medical Center

Study Description
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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
Cancer Drug: Normal Saline Group Drug: Heparin Group Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 12, 2020
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arms and Interventions
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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 Name: 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 Name: NS Flush, Normal Saline Flush, 0.9% Normal Saline Flush


Outcome Measures
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Primary Outcome Measures :
  1. Patency [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05029596


Contacts
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Contact: Meredith C Allen (817) 988-9905 meredith.allen@utsouthwestern.edu

Locations
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United States, Texas
Clements University Hospital Recruiting
Dallas, Texas, United States, 75390
Contact: Meredith C Allen, RN    214-633-1100    meredith.allen@utsouthwestern.edu   
Contact: Linda Denke    214-648-1810    linda.denke@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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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
More Information
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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: August 31, 2021    Key Record Dates
Last Update Posted: August 30, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, University of Texas Southwestern Medical Center:
Peripherally Inserted Central Lines
Heparin Flush
Additional relevant MeSH terms:
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Heparin
Calcium heparin
Anticoagulants
 Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action